QA Manager – QP
This Biopharmaceutical company focuses on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. A global leader in complement inhibition, and has developed and markets products as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation.
- Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing and product supply.
- Acts as quality point person, providing guidance and feedback on quality assurance issues.
- Act as designee for the department manager in their absence.
- Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
- Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Clinical and Commercial Operations groups.
- Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products.
- Ensure relevant QA documents and procedures are approved to schedule to support technology (external and internal) transfers and new product introductions.
- Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
- Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
- Actively contributes to continuous improvement activities.
- A minimum of 5-8 years relevant experience within the pharma industry or a related field.
- A minimum of 3 years supervisory experience.
- QP Qualified is essential, with on-license experience.
- Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required..
- Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, IMB/EMA or other authorities of similar standing.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: €0 - €76000