QC Associate

3 weeks ago

Singapur, Singapore Manpower Singapore Full time

QC Associate - System Support (Equipment Qualification/ Validation/Pharma)

Location: Gul Circle

Salary Up to $5,000 depending on experience

Completion Bonus: 1 Month

Our client delivers vital healthcare solutions worldwide, powered by the precision and dedication of its Manufacturing & Supply teams. With your talent, they can expand their impact—protecting more people and offering hope to patients and their families.

Responsibilities
  • Updating the site validation master plan 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; recommend method improvements where appropriate.
  • Support the life cycle management of QC lab equipment, i.e., qualification of QC equipment and periodic reviews maintained for their intended use.
  • Decommissioning of QC equipment and maintaining up-to-date lab equipment inventory.
  • Participate in proper documentation issuance and review of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports.
  • Support laboratory qualification investigations and resolve quality control events, issues or discrepancies within scope; implement remediation actions from findings and CAPAs.
  • Provide support during regulatory inspections and audits.
  • Prepare metrics and monitoring data for qualification and validation activities to identify trends and issues during life cycle management of QC laboratory equipment.
  • Support initiatives for continuous improvement in QC support processes related to lab equipment management in coordination with QC excellence team.
  • Support invalid assay trending program in the QC laboratory.
  • Record all expected raw data, calculations, information related to tasks to comply with cGMP and data integrity requirements.
  • Perform tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, and records related to these tasks.
Requirements
  • Minimum of two (2) years of experience in quality control within the pharmaceutical industry, including good knowledge of Good Manufacturing Practices (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.
  • Keen attention to detail 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 good laboratory practices, good documentation practice and data integrity requirements.
  • Experienced in analytical method continuous monitoring requirements.
  • Excellent interpersonal relationships to establish the partnerships necessary for the development of a quality culture.
Contact

Lim Pey Chyi -

Recruitment Consultant (R ) — Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

Notes: The following conveys consent to the collection, use and disclosure of personal data by ManpowerGroup Singapore for the purpose of carrying out its business, in compliance with the Personal Data Protection Act 2012. For details, visit the ManpowerGroup privacy policy.

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