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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 and experienced Quality Assurance Specialist to manage and ensure compliance with quality assurance processes and regulatory requirements. The successful candidate will be responsible for acting as the company's Representative in Austria, upholding GDP requirements, and serving as a backup resource for the German affiliate.
Key Responsibilities:- Oversee compliance with EU Good Distribution Practices, Quality Assurance standards, and relevant GxP regulations.
- Implement Quality Management Systems and relevant SOPs in the Austrian office to ensure alignment with EU-GMP, EU-GDP Guidelines, and local legislation.
- Highlight and act on any deviations found in temperature and humidity data logged during transportation.
- Support the management, development, and optimization of the local quality system as part of the implementation for the European QMS.
- Handle GxP-related tasks, including documentation system, deviations, change control, CAPA, customer complaints, recall management, and training system.
- Provide required data analysis and KPI reporting consistently.
- Ensure timely response to requests from local regulatory authorities according to respective national legislation and monitor follow-up actions diligently.
- 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.
- Bonus
- Relocation
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