quality assurance specialist in dublin

posted
job type
permanent
apply now

job details

posted
location
dublin
job category
pharmaceutical
job type
permanent
working hours
Full-Time
reference number
ZOE9
apply now

job description

Responsibilities



* Evaluation, Approval & Monitoring of vendors including Quality Agreements
* Provide QA support to Operations in terms of ensuring that GMP activities are in compliance with regulatory, corporate and site procedures.
* Provide QA support for Deviations, CAPA's, Change control,Cleaning Validation and Quality reviewer of SOPs, EOPs,Change Requests, Protocols, Reports, etc.
* Review /Approve Master Batch Record (MBR),Review Batch Records / Review Cleaning Records as per the site procedures.
* Perform/Lead Internal Audits/Quality Walkthroughs
* Quality Oversight of Warehouse and GMP Service Providers
* Manage Vendor audits from planning to close out.
* Support Internal Inspection Readiness, Corporate and Regulatory Inspections.
* Serving as a quality culture role model and instil a strong quality and compliance culture
* Assure the use of operational excellences tools in quality procedures and processes,
* Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work.
* Active participation in site Tier meetings
* Comply with the relevant Safety Statutory provisions

Qualifications



* Undergraduate degree in pharmaceutical, biological or chemical sciences
* 1-10 years relevant experience in Pharmaceutical industry with a current knowledge of cGMP's and regulatory guidance
* Experience in QA supplier management and ISO 9001 and/or Regulatory Affairs is desirable.
* Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles
* ICHQ7 Manufacturing Site experience preferred
* Recognised LSS Qualification desirable
* Demonstrated knowledge and success
* Ability to develop and adhere to self-directed standard work- organized and methodical with ability to take initiative
* Strong written and oral communication skills and ability work in a team
* Strong interpersonal, leadership and influencing skills
* Drives for Superior Results and Passion to Win with demonstrated record in getting things done
* Inspires Continuous Improvement and Breakthrough Thinking - flexible and adaptable to new and innovative ideas
* Ability to manage multiple projects simultaneously and prioritize work, goals and tasks
* Demonstrated written communication skills, as well as experience with presenting to leadership teams.

Apply now to take you career to the next level !

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Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional 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