Quality Assurance Specialist pharmaceuticals F/M/X
il y a 3 semaines
Provide QA support for External Manufacturers in the EMEA region.
Assist in the development of corrective action plans and monitor implementation. Assist in the development, writing and implementation of quality procedures.
Provide QA support for improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products.
Support investigations, collect data, analyze trends, and prepare reports as required.
- Assist to assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.
- Monitor trends, identify issues, recommend and implement appropriate actions.
- Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
- Coordinate and provide concurrences on deviations, change controls and CAPAs.
- Participate in audits of External Manufacturers.
- Assist with regulatory inspections and provides follow up on regulatory commitments.
- Develop, implement, and review of SOPs for interactions with External Manufacturers.
- Investigate customer product quality complaints.
- Apply cGMP regulations and other international requirements to all aspects of the position.
- Coordinate change control documentation and approval process.
- Provide Quality oversight.
- Interface with other functions (Operations, Planning, Technical Operations, etc)
ENGLISH fluent mandatory
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Seniority levelMid-Senior level
Employment typeFull-time
Job functionOther
IndustriesPharmaceutical Manufacturing
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