2 jobs found for biotechnology pharmaceutical

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    • bülach, aargau
    • contract
    Quality & Compliance Manager Medical AffairsDo you have experience working in quality and clinical processes? Do you enjoy working in the medical device industry and are not afraid of taking on a new challenge? In this case, you should have a look at this opportunity! Our client, a world leading medical device manufacturer in Zürich area is looking for a: Quality & Compliance Manager Medical Affairs(Permanent position - to start ASAP) Your Responsibilities : You will assure the compliance with guidelines, regulations and procedures in respect to clinical processes  You will work on quality process management and contribute to harmonization of QMS within global environment  You will perform quality checks internal and at the site  You will be responsible for training and qualification activities in respect to Medical Affairs department and regions  You will be performing and leading vendor qualifications/audits for external suppliers of clinical services  You will act as an interface between MA and its external stakeholders in regards to quality aspects in medium to high complex questions  You will be leading the execution of quality & compliance projects within the Medical Affairs department Your Profile : Work experience: 3-5 years proven experience in the medical device and clinical/regulatory field (i.e. clinical studies, post market surveillance etc.) Competencies & skills: University or bachelor’s degree in scientific, medical field or law or equivalent experience and background in medical or pharmaceutical within clinical studies and regulatory field required  Strong project and process management experience  Knowledge/Expertise in ISO 14155, MDD, MDR, GDPR, 21 CFR relevant parts, ISO 14971  Experience in (clinical) project work and experience as head of a work package within a project or programme  Detail oriented and communicative team player with strong project management skills  Strong self-starter and collaborator across all levels of the organization, within the business unit and with internal and external partners  Languages: Fluent in German and English (written and spoken) Experience as an internal auditor/co-auditor Quality & Compliance Manager Medical AffairsDo you have experience working in quality and clinical processes? Do you enjoy working in the medical device industry and are not afraid of taking on a new challenge? In this case, you should have a look at this opportunity! Our client, a world leading medical device manufacturer in Zürich area is looking for a: Quality & Compliance Manager Medical Affairs (Permanent position - to start ASAP) Your Responsibilities : You will assure the compliance with guidelines, regulations and procedures in respect to clinical processes  You will work on quality process management and contribute to harmonization of QMS within global environment  You will perform quality checks internal and at the site  You will be responsible for training and qualification activities in respect to Medical Affairs department and regions  You will be performing and leading vendor qualifications/audits for external suppliers of clinical services  You will act as an interface between MA and its external stakeholders in regards to quality aspects in medium to high complex questions  You will be leading the execution of quality & compliance projects within the Medical Affairs department  Your Profile : Work experience: 3-5 years proven experience in the medical device and clinical/regulatory field (i.e. clinical studies, post market surveillance etc.)  Competencies & skills: University or bachelor’s degree in scientific, medical field or law or equivalent experience and background in medical or pharmaceutical within clinical studies and regulatory field required  Strong project and process management experience  Knowledge/Expertise in ISO 14155, MDD, MDR, GDPR, 21 CFR relevant parts, ISO 14971  Experience in (clinical) project work and experience as head of a work package within a project or programme  Detail oriented and communicative team player with strong project management skills  Strong self-starter and collaborator across all levels of the organization, within the business unit and with internal and external partners  Languages: Fluent in German and English (written and spoken) Experience as an internal auditor/co-auditor   
    Quality & Compliance Manager Medical AffairsDo you have experience working in quality and clinical processes? Do you enjoy working in the medical device industry and are not afraid of taking on a new challenge? In this case, you should have a look at this opportunity! Our client, a world leading medical device manufacturer in Zürich area is looking for a: Quality & Compliance Manager Medical Affairs(Permanent position - to start ASAP) Your Responsibilities : You will assure the compliance with guidelines, regulations and procedures in respect to clinical processes  You will work on quality process management and contribute to harmonization of QMS within global environment  You will perform quality checks internal and at the site  You will be responsible for training and qualification activities in respect to Medical Affairs department and regions  You will be performing and leading vendor qualifications/audits for external suppliers of clinical services  You will act as an interface between MA and its external stakeholders in regards to quality aspects in medium to high complex questions  You will be leading the execution of quality & compliance projects within the Medical Affairs department Your Profile : Work experience: 3-5 years proven experience in the medical device and clinical/regulatory field (i.e. clinical studies, post market surveillance etc.) Competencies & skills: University or bachelor’s degree in scientific, medical field or law or equivalent experience and background in medical or pharmaceutical within clinical studies and regulatory field required  Strong project and process management experience  Knowledge/Expertise in ISO 14155, MDD, MDR, GDPR, 21 CFR relevant parts, ISO 14971  Experience in (clinical) project work and experience as head of a work package within a project or programme  Detail oriented and communicative team player with strong project management skills  Strong self-starter and collaborator across all levels of the organization, within the business unit and with internal and external partners  Languages: Fluent in German and English (written and spoken) Experience as an internal auditor/co-auditor Quality & Compliance Manager Medical AffairsDo you have experience working in quality and clinical processes? Do you enjoy working in the medical device industry and are not afraid of taking on a new challenge? In this case, you should have a look at this opportunity! Our client, a world leading medical device manufacturer in Zürich area is looking for a: Quality & Compliance Manager Medical Affairs (Permanent position - to start ASAP) Your Responsibilities : You will assure the compliance with guidelines, regulations and procedures in respect to clinical processes  You will work on quality process management and contribute to harmonization of QMS within global environment  You will perform quality checks internal and at the site  You will be responsible for training and qualification activities in respect to Medical Affairs department and regions  You will be performing and leading vendor qualifications/audits for external suppliers of clinical services  You will act as an interface between MA and its external stakeholders in regards to quality aspects in medium to high complex questions  You will be leading the execution of quality & compliance projects within the Medical Affairs department  Your Profile : Work experience: 3-5 years proven experience in the medical device and clinical/regulatory field (i.e. clinical studies, post market surveillance etc.)  Competencies & skills: University or bachelor’s degree in scientific, medical field or law or equivalent experience and background in medical or pharmaceutical within clinical studies and regulatory field required  Strong project and process management experience  Knowledge/Expertise in ISO 14155, MDD, MDR, GDPR, 21 CFR relevant parts, ISO 14971  Experience in (clinical) project work and experience as head of a work package within a project or programme  Detail oriented and communicative team player with strong project management skills  Strong self-starter and collaborator across all levels of the organization, within the business unit and with internal and external partners  Languages: Fluent in German and English (written and spoken) Experience as an internal auditor/co-auditor   
    • zug, zug
    • temporary
    Do you have a first experience in a GMP environment with sample and complaints handling ? Would you like to work in a dynamic multinational environment ? For our client, a biotech company in the Zug area we are looking for a Product Complaints Associate until July 2022, with the possibility of extensionTasks:- Role in the team- Coordinator of complaints and sample handling (40%)Processes incoming casesResponds to complaint originator queries and manages team email inbox- Quality Management system processes. (20%)Initiates/supports continuous improvement initiative/teams at a local or global level to address issues and resolutions with managerial support.Initiates/supports team efforts to simplify the process to reduce errors and non -added-value activities- Complaint data analysis (10%)Performs metric reporting including those related to assigned CMOs, partners, supplier review meetings and auditsCommunicate data trending, critical cases to impacted groups and managers.- Internal and external stakeholder management (10%)Participates in business relationships with internal departments as well as vendors and contractorDeliver external training, develop training content with particular attention to market-specific needs with respect to contractors, Affiliates, or DistributorsDelivers internal training, develops training content, and manages updates for both global and local process requirementsResponsible for ensuring Quality/ performance of internal/ external stakeholders against procedures.- Lab and sample investigation (10%)Perform sample evaluation as per the procedureSupport the creation of an investigation methodPerforms internal or external lab activities under management supervision and ensures processes comply to SOPs and GMP- The investigation, root cause, and corrective/ preventive action. (10%)Perform case investigation, monitoring correct CAPA follow-up for the established root cause.Manage sample returns and perform sample evaluation.Manage internal and external lab and compliance to established processes.Profile:Bachelor or Master in Life Science or EngineeringProficient in Word, Excel, Powerpoint.Fluent English (written and spoken) is a mustGMP knowledge1-2 years work experience in pharma or biotechApply now to your next challenge!
    Do you have a first experience in a GMP environment with sample and complaints handling ? Would you like to work in a dynamic multinational environment ? For our client, a biotech company in the Zug area we are looking for a Product Complaints Associate until July 2022, with the possibility of extensionTasks:- Role in the team- Coordinator of complaints and sample handling (40%)Processes incoming casesResponds to complaint originator queries and manages team email inbox- Quality Management system processes. (20%)Initiates/supports continuous improvement initiative/teams at a local or global level to address issues and resolutions with managerial support.Initiates/supports team efforts to simplify the process to reduce errors and non -added-value activities- Complaint data analysis (10%)Performs metric reporting including those related to assigned CMOs, partners, supplier review meetings and auditsCommunicate data trending, critical cases to impacted groups and managers.- Internal and external stakeholder management (10%)Participates in business relationships with internal departments as well as vendors and contractorDeliver external training, develop training content with particular attention to market-specific needs with respect to contractors, Affiliates, or DistributorsDelivers internal training, develops training content, and manages updates for both global and local process requirementsResponsible for ensuring Quality/ performance of internal/ external stakeholders against procedures.- Lab and sample investigation (10%)Perform sample evaluation as per the procedureSupport the creation of an investigation methodPerforms internal or external lab activities under management supervision and ensures processes comply to SOPs and GMP- The investigation, root cause, and corrective/ preventive action. (10%)Perform case investigation, monitoring correct CAPA follow-up for the established root cause.Manage sample returns and perform sample evaluation.Manage internal and external lab and compliance to established processes.Profile:Bachelor or Master in Life Science or EngineeringProficient in Word, Excel, Powerpoint.Fluent English (written and spoken) is a mustGMP knowledge1-2 years work experience in pharma or biotechApply now to your next challenge!

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