QA complaints analyst

Location: Breda, Noord-Brabant  |  Sector: Biotechnology  |  Start Date: 8/8/2023  |  Job ref: 51331

Job Title: QA complaints analyst
The Company: 
Our client is a global biotechnology company specializing in innovative therapies. Renowned for groundbreaking research in life-changing treatments. Committed to improving patients’ lives through cutting-edge science. A leading force in the healthcare industry, driving advancements worldwide.
Role Description:
In this role you will be providing QA guidance and assistance for production activities, including batch record review of assembled, packaged, and labeled batches. Foster productive relationships with Production, Warehouse, Maintenance, Engineering, QA Management, and the Qualified Person.

Responsibilities:

  • Serve as a primary point of contact for production-related quality inquiries during packaging and labeling operations, initiating, and overseeing QA deviations when required.
  • Perform GMP compliance checks during production, review and approve deviation records, and contribute to the development of operational SOPs and Work Instructions.
  • Collaborate on GMP training for QA and production teams, participate in QA-related projects, investigations, and improvement initiatives, while maintaining and updating departmental performance boards.
  • Hybrid role. It encompasses both PQA and the complaints lab.

Requirements:

  • BSc degree in Pharmaceutical/Life Sciences or a related field, or an equivalent blend of education and practical experience.
  • 0-1 years in Quality Assurance or manufacturing within the pharmaceutical or medical device sector
  • Expertise in reviewing batch records and conducting investigations.
  • Familiarity with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/or Good Clinical Practice (GCP)
  • Proficiency in manufacturing and/or quality analytical procedures and operations.
  • Willing to work in shifts.

Other information:
Are you prepared to start a fresh phase in your professional journey? If you or an individual you’re acquainted with is captivated by this chance, please don’t hesitate to contact me at +31 (0) 20 369 9255. Remember to select the apply option for sending in your CV. I’m enthusiastic about engaging in a dialogue with you concerning this thrilling pot

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