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    • wicklow, wicklow
    • permanent
    • full-time
    Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Responsibilities:Ensures manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations.Technical transfer, Scale-up & Installation of new processes & new unit operations onto and with-in the plant.Support Process & Facility start-ups, initial campaigns & process optimisation.Complete detailed Equipment and Process assessments.Project Management of wide scope cross functional projects.Application of Six Sigma and Lean methodologies when undertaking projects and coaching others in use of these tools as part of their application.Ensure campaign preparations for individual processes are achieved to facilitate on‐time campaign start‐up and adherence of agreed production rate.Takes ownership for assigned process steps and provide process technical support as required.Lead cross functional investigations within operations. Use lean six sigma tools to drive root cause analysis and CAPA completion.The preparation and routine review of Batch Records, Cleaning Procedures, Equipment Operating Procedures, Standard Operating Procedures, Protocols and Summary Reports. These updates include actively making changes to drive improvements, increase in RFT and decrease in deviations.The development and update of control system recipes.Participation in audits, quality monitoring inspections and self-inspections as required. Lead cycle time reduction initiatives.Participation and driving of Continuous Improvement Activities.Lead EHS activities including Process HAZOP.Preparation of change control packages.Skills and Experience:3 to 5 years of experience in a technical role in the Pharmaceutical industry.Degree in Chemical/Process Engineering or Chemistry.Technical skills and competencies:Strong leadership, communication, decision making and problem solving skills.Experience with 6 sigma or other operational excellence tools.Experience of working in a cross functional team in a highly regulated environment.Experience of technology transfer and a new product/equipment start-up.An understanding of computer control systems, P.I.D loops and interlock devices.Ability to manage multiple projects simultaneously and prioritise work, goals and tasks in accordance with division and corporate objectives.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
    Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Responsibilities:Ensures manufacturing operations are continually supported and maintained in compliance with all quality, safety and environmental regulations.Technical transfer, Scale-up & Installation of new processes & new unit operations onto and with-in the plant.Support Process & Facility start-ups, initial campaigns & process optimisation.Complete detailed Equipment and Process assessments.Project Management of wide scope cross functional projects.Application of Six Sigma and Lean methodologies when undertaking projects and coaching others in use of these tools as part of their application.Ensure campaign preparations for individual processes are achieved to facilitate on‐time campaign start‐up and adherence of agreed production rate.Takes ownership for assigned process steps and provide process technical support as required.Lead cross functional investigations within operations. Use lean six sigma tools to drive root cause analysis and CAPA completion.The preparation and routine review of Batch Records, Cleaning Procedures, Equipment Operating Procedures, Standard Operating Procedures, Protocols and Summary Reports. These updates include actively making changes to drive improvements, increase in RFT and decrease in deviations.The development and update of control system recipes.Participation in audits, quality monitoring inspections and self-inspections as required. Lead cycle time reduction initiatives.Participation and driving of Continuous Improvement Activities.Lead EHS activities including Process HAZOP.Preparation of change control packages.Skills and Experience:3 to 5 years of experience in a technical role in the Pharmaceutical industry.Degree in Chemical/Process Engineering or Chemistry.Technical skills and competencies:Strong leadership, communication, decision making and problem solving skills.Experience with 6 sigma or other operational excellence tools.Experience of working in a cross functional team in a highly regulated environment.Experience of technology transfer and a new product/equipment start-up.An understanding of computer control systems, P.I.D loops and interlock devices.Ability to manage multiple projects simultaneously and prioritise work, goals and tasks in accordance with division and corporate objectives.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
    • wicklow, wicklow
    • permanent
    • full-time
    Chemical Engineer Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Responsibilities Support process & facility start-up initiatives.Support HAZOP/ process risk assessments plan.Support the engineering department in the application of Process Safety elements. Assist with technology transfer of API processes, including process fit, identification of equipment needs, and facility modifications.Provide oversight for Mechanical Integrity Programs (I&E, Fire Protection, Equipment, RVs, Piping, etc.)Collaborate closely with Operations colleagues in the preparation of Master Batch Records and execution of process HAZOPs, Hazard identification, risk assessments and chemical agent risk assessments and FMEAs for tech transfer of API processes.Supporting improvement of chemical manufacturing process safety performance, product transfers and new product introductions.Assist in the design and implementation of reliable and cost-effective engineering solutionsFacilitate the management of change processes from a process safety perspective.Collect and analyze technical data, generate reports including conclusions and recommendations where needed.Manage close out actions for production/projects etc. RequirementsAn honours degree in Chemical Engineering or related discipline.Minimum 2 year's experience in Pharmaceutical Manufacturing.Experience working in an API environment, desirable.Knowledge of mechanical systems (HVAC systems, power generation, utilities)Ability to read engineering drawings.Mastery of chemical engineering principles, practices and theories with pharmaceutical experience.Experience with scale-up techniques for processes from laboratory to plant scale.Due to a high volume of applications only those progressing to the next stage will be contacted.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
    Chemical Engineer Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Responsibilities Support process & facility start-up initiatives.Support HAZOP/ process risk assessments plan.Support the engineering department in the application of Process Safety elements. Assist with technology transfer of API processes, including process fit, identification of equipment needs, and facility modifications.Provide oversight for Mechanical Integrity Programs (I&E, Fire Protection, Equipment, RVs, Piping, etc.)Collaborate closely with Operations colleagues in the preparation of Master Batch Records and execution of process HAZOPs, Hazard identification, risk assessments and chemical agent risk assessments and FMEAs for tech transfer of API processes.Supporting improvement of chemical manufacturing process safety performance, product transfers and new product introductions.Assist in the design and implementation of reliable and cost-effective engineering solutionsFacilitate the management of change processes from a process safety perspective.Collect and analyze technical data, generate reports including conclusions and recommendations where needed.Manage close out actions for production/projects etc. RequirementsAn honours degree in Chemical Engineering or related discipline.Minimum 2 year's experience in Pharmaceutical Manufacturing.Experience working in an API environment, desirable.Knowledge of mechanical systems (HVAC systems, power generation, utilities)Ability to read engineering drawings.Mastery of chemical engineering principles, practices and theories with pharmaceutical experience.Experience with scale-up techniques for processes from laboratory to plant scale.Due to a high volume of applications only those progressing to the next stage will be contacted.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
    • wicklow, wicklow
    • permanent
    • full-time
    Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.Company Profile65+ years of experience in animal health.Nearly $6 billion annual revenues.25 manufacturing sites around the world.10,000 employees worldwide of which 1,100 employees are committed to R&D.Benefits: Competitive salary and bonus. Pension contribution. Private Health Insurance. Life Assurance.Shared Ownership schemes. Responsibilities: Support the development of a Central Engineering Database and Centre of Excellence for API process plant.Engineering oversight of process plant equipment. Support the scoping and early Engineering design of new process introductions and process improvement projects.Scope, develop and lead new projects related to process plant equipment improvements. Ensure that process plant equipment is maintained in accordance with vendor & legislative requirements.Support the Safety Controls & Interlock strategy for the site.Support the development of the site strategy for process plant equipment risk assessments and compliance with Machinery Directive guidelines.Ensure our client and regulatory agency policies and standards for plant equipment are fully complied with including Quality, EHS, FDA, HPRA, EPA, HSA.Interface with regulatory agencies during site audits and walk downs.Work closely with EHS, Operations, Utilities, Automation and Maintenance personnel to ensure equipment is safe to operate & maintain.Education and Experience: Bachelor's Degree in Mechanical, Chemical, Process or Electrical Engineering, honours grade.3 years plus experience in GMP manufacturing environment.Understanding of GMP and Quality standards.Experience of the Operation and Maintenance of Manufacturing process systems within a regulated environment.Familiarity with Machinery Directive legislation & implementation within an ATEX environment would be an advantage. Due to a high volume of applicants only those progressing to the next stage will be contacted. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
    Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.Company Profile65+ years of experience in animal health.Nearly $6 billion annual revenues.25 manufacturing sites around the world.10,000 employees worldwide of which 1,100 employees are committed to R&D.Benefits: Competitive salary and bonus. Pension contribution. Private Health Insurance. Life Assurance.Shared Ownership schemes. Responsibilities: Support the development of a Central Engineering Database and Centre of Excellence for API process plant.Engineering oversight of process plant equipment. Support the scoping and early Engineering design of new process introductions and process improvement projects.Scope, develop and lead new projects related to process plant equipment improvements. Ensure that process plant equipment is maintained in accordance with vendor & legislative requirements.Support the Safety Controls & Interlock strategy for the site.Support the development of the site strategy for process plant equipment risk assessments and compliance with Machinery Directive guidelines.Ensure our client and regulatory agency policies and standards for plant equipment are fully complied with including Quality, EHS, FDA, HPRA, EPA, HSA.Interface with regulatory agencies during site audits and walk downs.Work closely with EHS, Operations, Utilities, Automation and Maintenance personnel to ensure equipment is safe to operate & maintain.Education and Experience: Bachelor's Degree in Mechanical, Chemical, Process or Electrical Engineering, honours grade.3 years plus experience in GMP manufacturing environment.Understanding of GMP and Quality standards.Experience of the Operation and Maintenance of Manufacturing process systems within a regulated environment.Familiarity with Machinery Directive legislation & implementation within an ATEX environment would be an advantage. Due to a high volume of applicants only those progressing to the next stage will be contacted. Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
    • wicklow, wicklow
    • permanent
    • full-time
    Site Compliance and Product Release Lead Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile65+ years of experience in animal health.Nearly $6 billion annual revenues.25 manufacturing sites around the world.10,000 employees worldwide of which 1,100 employees are committed to R&D. Position SummaryThis position reports directly to the Site Quality Leader and will serve as the Quality Compliance and Product Release Manager for the Site. The Compliance and Product Release Lead will be the system owner for Auditing and Regulatory Inspection Management and have overall responsibility, working closely with the Quality Systems and Standards Lead, to ensure continuous site inspection readiness. The role will be responsible for Regulatory Compliance Surveillance and application for the Site QMS. Position ResponsibilitiesOversee Site License registration process.Approve Laboratory, Manufacturing and Packaging Master Batch Records.Ensure that Product release is in compliance with the registration files (QP) and fulfill the role of QP Batch Release Responsibility.Assuring Site Regulatory Compliance to Registrations via the Regulatory Change Management process, dossier harmonisation and working closely with Global Regulatory Affairs and Veterinary Medicines Research & Development (VMRA/VMRD) colleagues.Manage the timeliness and effectiveness of the Site completion and use of Annual Product Reviews (APRs).Lead the Site internal audit program, proactively identifying improvement opportunities and agreeing/prioritising improvement actions with Site stakeholders to ensure continuous inspection readiness.Lead Site regulatory inspections, preparation for and agreeing to remediation and CAPA plans with Regulatory Agencies.Consolidating outcomes and conducting risk assessment of BOH audits, GQCA audits, regulatory letters, manufacturing alerts and other relevant documents for the Site and its contractors or suppliers to identify trends and ensure CAPA plan is monitored, implemented, and effective.Leading the Site external contract service providers (CSP's) and suppliers audit program.Consolidating audit data for tracking/trending for compliance communications to Site and above site respective Leadership Teams.Responsible Contact for Site License Registration Process and Management of GMP Certificates.Assuring Site Regulatory Compliance to Registrations via the Regulatory Change Management process and execution of Lead Site Regulatory Role (compliance Network Member), working closely with Global Regulatory Affairs and Veterinary Medicines Research & Development (VMRA/VMRD) colleagues.Work with the site QSS Lead to Design, deploy and maintain compliant, robust, aligned, lean and efficient quality systems and tools at the site, which are aligned with Quality Risk Management Principles and which support GMS and commercial strategy, and support the product life cycle.Monitor Internal and External Factors Impacting the Pharmaceutical Quality System (i.e., emerging regulations, innovations that might enhance the pharmaceutical quality system).New Product Introduction - assure that all applicable quality aspects are met.Immediate notification to the Site Quality Head of any quality issues, and provide accurate and relevant information as required by the business.Serving as a quality culture role model and instil a strong quality and compliance culture across the site.Lead people development and succession plans for the Quality Compliance and Product Release function.Provide coaching/feedback to enhance the group and individual's professional performance and development,keeping succession plans updated to minimise hiring lags as roles become open in the group. Education, Qualifications and Experience Undergraduate degree in pharmaceutical, biological, chemical sciences, or engineering.Relevant advanced degree preferred.QP Eligibility desired.Minimum of 8 years progressive experience in the quality control, quality assurance, manufacturing operations in human or animal health. Current knowledge of cGMP's and demonstrated leadership of Regulatory Inspection Management and Regulatory Affairs.Recognised Lean Six Sigma Qualification (Green Belt or Black belt) desirable.Working knowledge of ICHQ10 key principles.Fluency in quality systems and regulatory compliance.Demonstrated ability in leading / managing people.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
    Site Compliance and Product Release Lead Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile65+ years of experience in animal health.Nearly $6 billion annual revenues.25 manufacturing sites around the world.10,000 employees worldwide of which 1,100 employees are committed to R&D. Position SummaryThis position reports directly to the Site Quality Leader and will serve as the Quality Compliance and Product Release Manager for the Site. The Compliance and Product Release Lead will be the system owner for Auditing and Regulatory Inspection Management and have overall responsibility, working closely with the Quality Systems and Standards Lead, to ensure continuous site inspection readiness. The role will be responsible for Regulatory Compliance Surveillance and application for the Site QMS. Position ResponsibilitiesOversee Site License registration process.Approve Laboratory, Manufacturing and Packaging Master Batch Records.Ensure that Product release is in compliance with the registration files (QP) and fulfill the role of QP Batch Release Responsibility.Assuring Site Regulatory Compliance to Registrations via the Regulatory Change Management process, dossier harmonisation and working closely with Global Regulatory Affairs and Veterinary Medicines Research & Development (VMRA/VMRD) colleagues.Manage the timeliness and effectiveness of the Site completion and use of Annual Product Reviews (APRs).Lead the Site internal audit program, proactively identifying improvement opportunities and agreeing/prioritising improvement actions with Site stakeholders to ensure continuous inspection readiness.Lead Site regulatory inspections, preparation for and agreeing to remediation and CAPA plans with Regulatory Agencies.Consolidating outcomes and conducting risk assessment of BOH audits, GQCA audits, regulatory letters, manufacturing alerts and other relevant documents for the Site and its contractors or suppliers to identify trends and ensure CAPA plan is monitored, implemented, and effective.Leading the Site external contract service providers (CSP's) and suppliers audit program.Consolidating audit data for tracking/trending for compliance communications to Site and above site respective Leadership Teams.Responsible Contact for Site License Registration Process and Management of GMP Certificates.Assuring Site Regulatory Compliance to Registrations via the Regulatory Change Management process and execution of Lead Site Regulatory Role (compliance Network Member), working closely with Global Regulatory Affairs and Veterinary Medicines Research & Development (VMRA/VMRD) colleagues.Work with the site QSS Lead to Design, deploy and maintain compliant, robust, aligned, lean and efficient quality systems and tools at the site, which are aligned with Quality Risk Management Principles and which support GMS and commercial strategy, and support the product life cycle.Monitor Internal and External Factors Impacting the Pharmaceutical Quality System (i.e., emerging regulations, innovations that might enhance the pharmaceutical quality system).New Product Introduction - assure that all applicable quality aspects are met.Immediate notification to the Site Quality Head of any quality issues, and provide accurate and relevant information as required by the business.Serving as a quality culture role model and instil a strong quality and compliance culture across the site.Lead people development and succession plans for the Quality Compliance and Product Release function.Provide coaching/feedback to enhance the group and individual's professional performance and development,keeping succession plans updated to minimise hiring lags as roles become open in the group. Education, Qualifications and Experience Undergraduate degree in pharmaceutical, biological, chemical sciences, or engineering.Relevant advanced degree preferred.QP Eligibility desired.Minimum of 8 years progressive experience in the quality control, quality assurance, manufacturing operations in human or animal health. Current knowledge of cGMP's and demonstrated leadership of Regulatory Inspection Management and Regulatory Affairs.Recognised Lean Six Sigma Qualification (Green Belt or Black belt) desirable.Working knowledge of ICHQ10 key principles.Fluency in quality systems and regulatory compliance.Demonstrated ability in leading / managing people.Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003

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