Senior Specialist, Quality Assurance | Alexion Pharmaceuticals, Inc. | Athlone, Ireland
Responsible for delivery of quality assurance activities at Alexion’s Irish locations to ensure commercial and/or clinical products are manufactured in accordance with cGMP, Corporate and Regulatory requirements. This responsibility requires the delivery of QA and compliance support for the Irish site(s).
The Senior Quality Assurance Specialist executes the site QA activities at Alexion in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Site Services, Engineering and Planning to optimize patient supply.
- Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to Alexion 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 an advantage
- 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.
- Excellent accuracy and attention to detail
- Good knowledge of relevant computer packages e.g. Trackwise or similar
- Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
- High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
- The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a responsible and professional manner.
- Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
- Third level qualification e.g. B.Sc . in science/pharmacy with a minimum of years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
- Qualified Person eligibility is desirable.