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Quality Assurance Specialist
vor 1 Monat
Fraser Dove International is partnering exclusively with a leading pharmaceutical organization specializing in generics. Our client is committed to improving people's lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.
Job Summary:We are seeking a highly skilled QA Specialist to manage and ensure compliance with quality assurance processes and regulatory requirements. The successful candidate will act as the company's Responsible Person (RP) to uphold GDP requirements in the Austrian affiliate and serve as a backup resource for the German affiliate.
Key Responsibilities:- Acting as the company's RP to uphold GDP requirements in the Austrian affiliate and serving as a backup resource for the German affiliate.
- Overseeing compliance with EU Good Distribution Practices, Quality Assurance standards, and relevant GxP regulations.
- Implementing Quality Management Systems and relevant SOPs in the Austrian office to ensure alignment with EU-GMP, EU-GDP Guidelines, and local legislation.
- Highlighting and acting on any deviations found in temperature and humidity data logged during transportation.
The successful candidate will support the management, development, and optimization of the local quality system as part of the implementation for the European QMS.
Regulatory Compliance:The QA Specialist will ensure timely response to requests from local regulatory authorities according to respective national legislation and monitor follow-up actions diligently.
Additional Responsibilities:The candidate will offer support to other affiliates and participate in local/regional projects on an ad hoc basis, as required.
Requirements:- Bachelor's or Master's degree in Life Sciences, such as Chemistry, Biology, Biochemistry, or Pharmacy.
- Skilled in interpreting documents and asking probing questions to quickly gather necessary supporting information.
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