Equipment Validation Specialist

13 hours ago

Singapore beBeeQuality Full time $5,500
Quality Assurance Specialist - Equipment Validation

We are seeking a Quality Assurance Specialist to join our team in the validation of equipment used in our pharmaceutical operations.

Key Responsibilities
  • Develop and maintain site validation master plans and procedures related to ALCM and CPV of GXP lab equipment.
  • Support periodic analytical method control trend review/investigation and data evaluation on method performance, recommending improvements where necessary.
  • Support the life cycle management of QC lab equipment, including qualification and periodic review for intended use.
  • Decommission equipment and maintain up-to-date lab equipment inventory.
  • Participate in documentation issuance and review of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
  • Support laboratory qualification investigation and resolving quality control events, issues or discrepancies.
  • Provide support during regulatory inspections and audits.
  • Prepare metrics and monitoring data for qualification and validation activities, identifying trends and issues.
  • Support initiatives for continuous improvement in QC support processes related to lab equipment management.
  • Support invalid assay trending program in the QC laboratory.
Requirements
  • Minimum two years' experience in quality control within the pharmaceutical industry, including good knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
  • Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life sciences or technology.
  • Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
  • Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
  • Good understanding of good laboratory practices, good documentation practice and data integrity requirements.
  • Experienced in analytical method continuous monitoring requirements.
  • Strong interpersonal relationships to establish partnerships necessary for quality culture development.
What We Offer
  • A dynamic work environment with opportunities for professional growth and development.
  • A chance to work with a talented team of professionals dedicated to delivering high-quality products and services.
  • The opportunity to make a meaningful contribution to the success of our organization.

Industry: Healthcare, Pharmaceuticals
Traits: Attention to detail, Continuous Improvement, Data analysis, Laboratory skills, Problem-solving, Regulatory compliance, Team player

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