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Barden are delighted to be supporting our Global Biopharmaceutical client in their search for a Principal QA Representative for their state-of-the-art manufacturing facility in Cork.
ABOUT THE ROLE:
The API (Active Pharmaceutical Ingredient) External Manufacturing Quality Assurance representative will provide support to all quality activities at Contract Manufacturing organizations (CMs). The QA representative is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
Roles & Responsibilities:
- Serve as a liaison between CMs and client.
- Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
- Escalate quality issues at CMs to QA management.
- Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Provide quality oversight of Quality Plans.
- Coordinate and perform QA responsibilities of API shipments.
- Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
- Participate on the Technical Review Board.
- Evaluate and disposition API batches, if required.
- Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
- Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
- Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
- Ensure all processes are in an appropriate state of control.
- Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
- Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
- Participate in APR activities.
- Participate in projects to improve productivity.
- Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams
ABOUT THE PERSON:
Education & Work Experience:
- BS (Hons) in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- 3+ years of previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.
Hi, we’re Barden. We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.
