Quality Assurance Specialist
hace 3 semanas
The Quality Assurance Specialist plays a crucial role in ensuring the maintenance of the national quality management system at the local level, adhering to GMP regulations and corporate guidelines. This position is responsible for supporting the self-inspections, external audits, and internal audits, as well as managing the follow-up of CAPAs implementation.
About the RoleThis is a temporary contract opportunity that offers a unique chance to contribute to the quality management system of Advanced Accelerator Applications (Italy) - S...
Key Responsibilities- Participate in self-inspections and external audits to ensure compliance with GMP regulations and corporate guidelines.
- Manage the follow-up of CAPAs implementation and ensure the respect of GMPs and Health Authorities requirements at the local level.
- Safeguard the quality of medicinal products manufactured by the radiopharmaceutical site.
- Support the achievement of APR goals and ensure the correct registration and archiving of documentation at the local level.
- Execute qualification, maintenance, calibration, and revalidation programs at the local level.
- Ensure the accomplishment of ALCOA+ principles and address Out of specifications, Out of trends, deviations, CAPA, and Change controls according to cGMP and SOPs.
- Participate in the execution of staff GMP training and respect the training annual plan.
- Escalate critical issues to the Quality Site Head and Quality National Head.
- Education: Scientific Degree (Pharmacy, Chemistry, Biology, or similar).
- 2+ years of experience in a Quality Assurance department.
- Strong affinity with and awareness of quality issues.
- Good organizational skills, including attention to details.
- Solid knowledge of quality systems (GMP) and basic knowledge of regulatory requirements.
- Fluent English and Spanish (written and spoken).
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