Aktuelle Jobs im Zusammenhang mit Quality Assurance Specialist - Munich, Bayern - Fraser Dove International
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Quality Assurance Specialist
vor 2 Monaten
We are seeking a highly skilled Quality Assurance Specialist to join our team at Fraser Dove International. As a key member of our organization, you will be responsible for ensuring compliance with quality assurance processes and regulatory requirements.
Key Responsibilities- Regulatory Compliance: Oversee compliance with EU Good Distribution Practices, Quality Assurance standards, and relevant GxP regulations.
- Quality Management Systems: Implement Quality Management Systems and relevant SOPs in the Austrian office to ensure alignment with EU-GMP, EU-GDP Guidelines, and local legislation.
- Documentation Control: Manage batch documentation effectively and ensure timely dispositioning of products for the Austrian market.
- Customer Interface: Act as the primary customer interface for complaints, complaint samples, and complaint close-out letters.
- Quality System Management: Support the management, development, and optimization of the local quality system as part of the implementation for the European QMS.
- Regulatory Affairs: Monitor and maintain local databases of various Quality Systems (e.g., change control, deviation, CAPA, complaint, training).
- Audits and Inspections: Prepare for audits and inspections thoroughly and perform self-inspections and follow-up activities.
- Data Analysis and Reporting: Provide the required data analysis and KPI reporting consistently.
- Education: Bachelor's or Master's degree in Life Sciences, such as Chemistry, Biology, Biochemistry, or Pharmacy.
- Experience: At least 2 years of experience in pharmaceutical quality and distribution, with practical experience as an RPi.
- Skills and Attributes: Strong analytical thinking and problem-solving skills, ability to remain calm under pressure, effective prioritization and multi-tasking abilities, and excellent verbal and written communication skills.
- Competitive Salary
- Bonus
- Healthcare
- Pension
- Relocation
