Job Description
We are seeking a Quality Assurance Specialist to join our Site Quality Unit based in Milton Keynes. This pivotal role involves ensuring that our production processes operate in full compliance with Good Manufacturing Practices (GMP) and corporate governance requirements. You will work closely with site management and support compliance during inspections, audits, and investigations.
Key Responsibilities:
1. Review and confirm batch records and quality control results to ensure compliance with production dossiers, procedures, and GMP guidelines
2. Communicate effectively with various departments regarding the status of batch documentation and prepare necessary documentation for Qualified Person (QP) review
3. Review deviations and Corrective and Preventive Actions (CAPAs) as the QA representative and participate in cross-functional investigations
4. Maintain the change control system, working with departments to assess impacts and ensure timely review, implementation, and closure
5. Review and approve operational procedures across departments, ensuring that Quality Assurance Standard Operating Procedures (SOPs) are clear and up to date
6. Conduct self-inspections and participate in corporate audits and regulatory inspections
Qualifications, Skills & Experience:
1. Bachelor’s degree or equivalent in a relevant field, coupled with experience in cGMP and quality management systems
2. Experience in the pharmaceutical industry, specifically within Quality Assurance
3. Familiarity with pharmaceutical manufacturing processes
4. Proficiency in technical report writing and database management
5. In-depth knowledge of current regulatory requirements for the manufacture of licensed medicinal products
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