As a Quality Assurance Officer, you are responsible for ensuring quality within our laboratory and operational processes. You will work according to GxP, ISO, and internal quality standards and play a key role in documentation control, audits, training, and compliance.
Your responsibilities include:
- Manage and assess deviations, changes, complaints, OOS, and CAPA in accordance with GMP guidelines.
- Maintain and monitor the change control and deviation systems.
- Perform routine quality assurance tasks according to SOPs and quality standards.
- Contribute to the assurance of the quality system based on regulatory requirements (and implementation of regulatory changes).
- Participate in QA system initiatives and improvement projects.
- Train personnel on GMP and quality procedures.
- Conduct (internal) audits and support external inspections (e.g., by regulatory authorities).
- Execute, report, and follow up on self-inspections.
- Create and revise QA procedures and work instructions.
- Maintain the GMP documentation system and archive, including electronic systems.
- Support the creation, review, or updating of QA agreements.
- Manage documentation and compliance related to opiates and precursors.
- Oversee the implementation of new equipment from a QA perspective.
- Ensure compliance in equipment metrology, including documentation.
- Review pest control reports and other facility-related quality documents.