Senior Quality Assurance Specialist

2 weeks ago

Singapore beBeeValidation Full time $90,000 - $120,000
Quality Assurance Lead

We are seeking a seasoned Quality Assurance professional with extensive experience in CQV (Commissioning, Qualification, and Validation) to spearhead quality initiatives and drive process excellence within the organization.

This is an exceptional opportunity for a motivated and detail-oriented individual to lead and participate in engineering, procurement, construction, and validation projects for GMP facilities. The ideal candidate will possess a strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, and ASME BPE regulations.

The successful candidate will be responsible for preparing, executing, and reviewing IQ, OQ, PQ validation protocols for equipment, facilities, and utilities. They will also conduct root cause analysis, lead quality investigations (deviations, CAPA, change control), manage validation schedules, and support manufacturing process setup and technical activities.

Requirements:
  • 8+ years of CQV experience in the pharmaceutical industry.
  • Strong understanding of regulatory requirements and industry standards.
  • Proven problem-solving and project coordination skills.
  • Excellent communication abilities.
  • Bachelor of Science in Chemical/Biological Engineering or related field.

Candidates should have hands-on experience with Delta V, Kneat, Veeva, and Trackwise systems. A strong understanding of risk assessment, construction, and commissioning processes is also essential. The selected candidate will be expected to work effectively in a team environment and communicate complex ideas to both technical and non-technical stakeholders.

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