Job Description

CQV – Quality Assurance Specialist (Co. Meath) To work for our client on a large scale Hi Tech State of the art Biologics facility in Co. Meath.

Your role will be to provide Quality oversight on the design and qualification activities as part of the design, construction, qualification and start-up of the new state of the art  facility at the Dunboyne site.

Suitable candidates will have a relevant Science / Engineering 3^rd level degree plus

• Significant experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
• Strong experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
• Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500.
• Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
• Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
• Track record of utilizing Risk Based Approaches to Qualification / Validation activities.
• Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.

Main Responsibilities include:

• Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
• Quality SME for the execution and reporting phases of the qualification and validation activities associated with the
• Review and Approve all documentation where required specific to Qualification / Validation activities.
• Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner.
• Oversee the Project Change Management Process and approve Project Change Requests where required.

This Biologics plant will be a premier, state-of-the-art facility that enables and advances best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions and will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.

For further information or to apply contact:  Tom Doyle at kppm, P: 086 8205038.  E: tom@kppm.ie

or email tom@kppm.ie

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