GXP Laboratory Quality Control Professional

4 days ago

Singapore beBeePharmaceutical Full time $4,000 - $5,000
Quality Control Specialist

Job Overview:

This is a key position responsible for ensuring the accuracy and reliability of quality control processes in a GXP laboratory setting.

  • Key Responsibilities:
  1. Supports the development and implementation of site validation master plans and procedures related to ALCM and CPV of GXP lab equipment.
  2. Participates in analytical method control trend review/investigation and data evaluation on method performance, recommending method improvements as necessary.
  3. Ensures the lifecycle management of QC lab equipment, including qualification, periodic review, and decommissioning.
  4. Maintains up-to-date records of lab equipment inventory and participates in proper documentation issuance and review of qualification and maintenance deliverables.
  5. Supports laboratory qualification investigations and resolves quality control events, issues or discrepancies within their scope. Implements remediation actions based on findings and CAPAs.
  6. Provides support during regulatory inspections and audits.
  7. Prepares metrics and monitoring data for qualification and validation activities to identify trends and issues during life cycle management of QC laboratory equipment.
  8. Collaborates with the QC excellence team to develop initiatives for continuous improvement in QC support processes related to lab equipment management.
  9. Supports invalid assay trending programs in the QC laboratory.

Required Skills and Qualifications:

  • Minimum two (2) years of experience in quality control within the pharmaceutical industry, including good knowledge of GMP and regulatory requirements, with hands-on exposure and theoretical understanding of QC laboratory instruments and ALCM management.
  • Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life sciences or Technology.
  • Excellent attention to detail and ability to ensure accuracy in testing, reporting, and regulatory compliance.
  • Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.
  • Good understanding of GxP, good laboratory practices, good documentation practice, and data integrity requirements.
  • Experience in analytical method continuous monitoring requirements.
  • Strong interpersonal relationships to establish partnerships needed for developing a quality culture.

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