We are currently looking for a QA Officer to join a leading Biopharmaceutical company based in the Kent area. As the QA Officer you will be responsible for evaluating and reviewing the company's clinical and commercial batches of drugs whilst ensuring that product and process documents match the required specifications.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Officer will be varied however the key duties and responsibilities are as follows:
1. You will contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
2. The QA Officer will review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to the company's policy and cGMP's.
3. Another responsibility is to accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact. You will also ensure that all documents received in the batch release area reviewed for completeness and accuracy.
4. It will be essential to provide Real Time Quality impact assessments and decisions on product and medical device issues, independently as well as maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
5. You will be given the opportunity to participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
To be successful in your application to this exciting opportunity as the QA Officer we are looking to identify the following on your profile and past history:
1. Relevant Bachelor's degree is required.
2. Proven industry experience within pharmaceuticals is essential as well as experience in Quality administered systems. The ideal candidate will also have experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
3. A working knowledge and practical experience of current Good Manufacturing Practices (part of GxP) is required for this position.
Key Words: Quality Assurance | QA Officer | Pharmaceuticals | GMP | CAPA | QMS | QRM | Manufacturing | RFT | PQR | Batch Release |