Validation Expert

2 weeks ago

Singapore beBeeLaboratory Full time $90,000 - $120,000
Job Description

Seeking a detail-oriented and certified professional to support laboratory operations in a regulated GMP environment. The role involves ensuring computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while driving continuous improvement initiatives.

The ideal candidate will possess excellent documentation skills, strong stakeholder collaboration abilities, and experience supporting audits and regulatory inspections.

Required Skills & Qualifications
  • 5+ years' experience in CSV within the pharmaceutical or biotechnology industry.
  • Hands-on experience with laboratory systems validation.
  • Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, and Annex 11 guidelines.
  • Experience managing system lifecycle activities, including change controls, periodic reviews, and data integrity assessments.
  • Excellent communication and interpersonal skills.
Key Responsibilities:
  1. Perform validation of QC systems such as LIMS, Empower, CDS, and other analytical equipment.
  2. Author and execute validation deliverables (URS, Risk Assessments, IQ/OQ/PQ, Traceability Matrix, Summary Reports).
  3. Manage system lifecycle activities, including change controls, periodic reviews, and data integrity assessments.
  4. Ensure audit and inspection readiness for validation documentation.
  5. Contribute to error-reduction and continuous improvement activities within laboratory operations.

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