Quality Control Analyst

6 dagen geleden

Amsterdam, Noord-Holland, Nederland Pharmaceutical Mfg. Company Voltijd

Job Title: QC Analyst

Location: Bilthoven, Netherlands

Employment Type: Full-time

Job Purpose

The QC Analyst is responsible for conducting analytical testing of finished products (FP) to ensure compliance with CGMP regulations, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). The role requires hands-on experience with laboratory instruments, documentation, and quality control processes in a pharmaceutical environment.

Key Responsibilities

1. Analytical Testing & Compliance

  • Perform instrumental analysis using HPLC, GC, FTIR, UV, and other analytical techniques .
  • Conduct analysis of FP samples as per the defined schedule.
  • Evaluate test results against specifications and report any abnormal observations such as OOS (Out of Specification), OOT (Out of Trend), and analytical incidents .
  • Follow GLP, GMP, and Good Documentation Practices (GDP) to maintain compliance.

2. Documentation & Regulatory Compliance

  • Maintain online documentation, ensuring accuracy, authenticity, and compliance with regulatory requirements.
  • Prepare and update documents as per GMP guidelines .
  • Dispose of tested samples and solutions per standard disposal procedures.

3. Laboratory Maintenance & Equipment Handling

  • Maintain laboratory cleanliness, organization, and compliance.
  • Perform validation, qualification, and calibration of instruments as per schedule.
  • Ensure timely availability of standards, glassware, and chemicals to avoid operational delays.

4. Continuous Improvement & Audits

  • Participate in GMP and customer audits and ensure compliance.
  • Identify process improvement and cost-saving opportunities through automation and efficiency enhancements.
  • Collaborate with internal and external teams to resolve non-conformances efficiently.

Key Challenges & Problem-Solving

  • Managing workflow disruptions due to planning changes → Addressed through performance dialogues and priority-setting meetings.
  • Minimizing delays due to instrument breakdowns → Ensured through proactive maintenance and coordination with service engineers.
  • Avoiding batch release delays due to resource shortages → Achieved by effective coordination and escalation as needed.

Key Interactions

  • Internal: Lab Planning Team, QA Team, Lab Assistants, QC Supervisors.
  • External: Service Engineers for instrument-related issues.

Qualifications & Experience

Must-Have:

Education:

  • B.Sc. Chemistry OR Bachelor of Pharmacy .
  • Dutch equivalent: MBO (Secondary vocational education) with 5+ years of experience OR HBO (Higher professional education) with 1-3 years of experience .

Experience:

  • 1-3 years of experience in a Quality Control function within the pharmaceutical industry.
  • Knowledge of CGMP regulations is required.

Skills:

  • Strong proficiency in instrumental analysis (HPLC, GC, FTIR, UV, etc.) .
  • Ability to handle OOS, OOT, and analytical incidents efficiently.
  • Proficiency in English (spoken and written).

Additional Information

  • Work Permit Requirement: Only candidates with European citizenship or permanent residency will be considered.
  • Candidate Location: Candidates must be based in the Netherlands (no relocation from outside the Netherlands).
  • Education Restrictions: No Master's degree candidates (only Bachelor's degree holders).
  • Interview Process: 2-3 rounds of interviews.
  • Notice Period: 0 to 30 days.
  • Relocation Assistance: Available for candidates within the Netherlands.
  • Strict No-Poach Policy: No candidates from the UK.

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