Aktuelle Jobs im Zusammenhang mit Quality Assurance Specialist - Olching, Bayern - Fraser Dove International
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Quality Assurance Specialist
vor 2 Monaten
Fraser Dove International is partnering exclusively with a leading pharmaceutical organization specializing in generics.
Our client is seeking a highly skilled professional to manage and ensure compliance with quality assurance processes and regulatory requirements.
Key Responsibilities:- Act as the company's Representative to uphold GDP requirements in the Austrian affiliate and serve as a backup resource for the German affiliate.
- 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 but not limited to: documentation system, deviations, change control, CAPA, customer complaints, recall management, and training system.
Data Analysis and Reporting:Provide the required data analysis and KPI reporting consistently.
Regulatory Compliance:Ensure timely response to requests from local regulatory authorities according to respective national legislation and monitor follow-up actions diligently.
Additional Support: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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