Expert Pharmaceutical Validation Professional

3 days ago


Singapore beBeeValidation Full time $108,000 - $153,000
Pharmaceutical Validation Specialist

We are seeking a skilled Commissioning, Qualification and Validation (CQV) professional to lead and participate in Engineering, Procurement, Construction and Validation for Good Manufacturing Practice (GMP) facilities.

Key Responsibilities:
  • Develop and execute IQ, OQ, PQ validation protocols for equipment, facilities and utilities.
  • Conduct root cause analysis and lead quality investigations.
  • Manage validation schedules and resource alignment.
  • Support manufacturing process setup and technical activities.
  • Perform FAT/SAT activities and temperature mapping.
  • Utilize industry-standard software such as Delta V, Kneat, Veeva and Trackwise.
Requirements:
  • At least 8 years of CQV experience in the pharmaceutical industry.
  • Strong understanding of cGMP, USP, EMA, ICH, 21 CFR and GAMP5 guidelines.
  • Proven problem-solving and project coordination skills.
  • Excellent communication abilities.
  • Bachelor's degree in Chemical or Biological Engineering or related field.

Preferred skills include USP, CAPA, Construction, Risk Assessment, GMP, Root Cause Analysis, Procurement, Python, Change Control, ASME and Project Coordination.



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