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Quality Assurance Specialist

vor 2 Monaten


Munich, Bayern, Deutschland Fraser Dove International Vollzeit
About the Role

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.
Requirements
  • 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.
What We Offer
  • Competitive Salary
  • Bonus
  • Healthcare
  • Pension
  • Relocation