QA Officer Job Description Template
Our company is looking for a QA Officer to join our team.
Responsibilities:
- To resolve manufacturing, testing, packaging and supply chain issues to support batch disposition;
- To complete all relevant documentation to support the QP in the release of drug products;
- You will maintain GMP compliance through auditing and providing training to colleagues on best practices;
- You will provide Quality support for GMP manufacture, both writing and reviewing GMP documentation;
- You will support on the maintenance and troubleshooting of electronic QMS for non-conformances and provide training where necessary;
- As the QA officer, you will be the primary QA contact during your time on site and will take ownership for Quality across all site areas;
- You will review and investigate any Deviations and issues relating to Quality Compliance within the bio-pharmaceutical GMP environment;
- You will support the management of the Quality Management System (QMS), ensuring timely completion of deviations, CAPAs and change controls;
- As the QA Officer, you will support Facility Systems with actions such as cleaning logs, temperature and pressures;
- You will assist in internal, supplier and external audits as required to maintain GMP compliance within the bio-pharmaceutical environment;
- As the QA Officer, you will control all Quality Documentation, issue SOPs and Batch Manufacturing Records (BMRs);
- To assist the certifying QP in the release of the drug product where required;
- To compile & review batch document sets for completeness & compliance to EU GMP;
- Assist the certifying QP in the release of the drug product where required within company systems;
- Compile & review batch document sets for completeness & compliance to EU GMP, internal requirements and regulatory dossier submissions.
Requirements:
- Degree or equivalent in a scientific discipline;
- Working knowledge and experience with a Quality Management system, such as deviations, investigations, CAPA, customer complaints, GDP incidents;
- Experience using root cause analysis tools and error risk reduction tools;
- Working knowledge of UK/EU and US regulatory requirements;
- Experience working in a quality role within the pharmaceutical industry;
- Working knowledge of GMP and GXP;
- Experience working with computer systems, MS office;
- Experience maintaing Quality Systems and resolving any issues;
- Experience in Batch Release, QP, Quality Assurance;
- Strong IT Skills – including ideally Trackwise or similar;
- Strong attention to detail and process-driven.