Quality Assurance Specialist Role
This is a challenging opportunity to join our quality team as a Quality Assurance Specialist. The successful candidate will be responsible for ensuring compliance with Good Manufacturing Practice (GMP) regulations.
* Bachelor's Degree in a scientific or technical discipline is required.
* A minimum of 3-5 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
The ideal candidate will have knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. They will be able to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
In this role, you will be responsible for carrying out tasks related to the management of Quality Assurance activities. This includes Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.
Main Responsibilities
Some of your key responsibilities will include:
1. Batch Record Review & material release to ensure compliance with GMP requirements.
2. Carrying out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
3. Carrying out tasks related to the management of batch records design and approval.
4. Carrying out administration of the SAP Quality Management Module.
5. Carrying out tasks relating to the management of site change control systems.
6. Compiling Annual Product Reviews.
7. SUPPORTING all validation activities on site as described in the Site Validation Master Plan.
8. Approving and compiling where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
9. SUPPORTING system qualification and process validation activities.
10. Reviewing and approving SOPs/work instructions/forms from other departments on behalf of Quality Assurance
11. CO-ORDINATING and assisting in the preparation for regulatory and customer GMP inspections of the site.
12. Participating in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
13. PERFORMING GMP audits on-site and vendor facilities as required.
14. Performing on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
15. Carrying out tasks related to the administration of site supplier approval process.