Provide Quality oversight on the design and qualification activities as part of the design, construction, qualification and start-up of the new facility.

Responsibilities

• 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 BioNX facility.
• 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.

Qualifications & Education

• 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.

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie