Senior Quality Assurance Officer

SENIOR QUALITY ASSURANCE OFFICER

MY CLIENT, A LEADING PHARMACEUTICAL COMPANY BASED IN HAVERHILL, SUFFOLK IS URGENTLY SEEKING AN EXPERIENCED SENIOR QUALITY ASSURANCE OFFICER TO JOIN THEIR TEAM FOR A MINIMUM OF 24 MONTHS WITH POTENTIAL FOR EXTENSION. THIS IS A FULL TIME ROLE WORKING BETWEEN THE HOURS OF 8AM- 4:30PM.

RESPONSIBLE FOR REVIEWING IN-HOUSE DOCUMENTATION IN ACCORDANCE WITH IN-HOUSE SPECIFICATIONS AND CGMP. WORKS TO MAINTAIN AND MANAGE QUALITY SYSTEMS REGARDING CGMP FOR THE SITE. SUPPORTS OR CARRIES OUT AUDITS AND INSPECTIONS TO ASSURE COMPLIANCE WITH REGULATIONS.

- Reviews GMP or regulatory documentation
- Liaises with internal and external third parties and may co-ordinate work done by different groups.
- Monitors third party compliance and follows up on non-compliance issues to ensure timely resolution or escalates appropriately.
- Provides advice and support to managers and resolves routine and some non-routine compliance or regulatory issues. May sign off some cGMP or Regulatory documents.
- Acts as departmental representative in projects or cross-functional meetings.
- Manages relevant systems and databases. Supports the continual improvement process and will be expected to generate new ideas for
- Has a good knowledge of cGMP, current legislation and regulations and how they impact on their Keeps up to date with changes.
- May facilitate internal! audits and inspections under directions and produce reports and action May act as a product steward-
- maintains knowledge of an assigned product, including being the point of contact for the business for quality related advice and support for that product
- May act as a point of contact for quality related advice and support for specific assigned functional areas
- May provide supervision and guidance on day to day matters to less experienced May act as a Site Standard Owner
- May act as a Quality IT System Co-ordinator

PLEASE APPLY ACCORDINGLY FOR IMMEDIATE CONSIDERATION. ALL CANDIDATES MUST BE WILLING TO UNDERGO CLEARANCE.