QC Associate

2 weeks ago

Singapur, Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full time

Overview

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

Location : Gul Circle

Salary Up to $4,500 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 the QC lab equipment i.e qualification of QC equipment and periodic review are maintained for their intended use.
  • Decommissioning of QC equipment and maintaining up to date the 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 investigation and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
  • Providing support during regulatory inspections and audits.
  • Prepare metrics and monitoring data for the 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.
  • Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements.
  • Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks.
Qualifications
  • 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 requirement 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 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 the partnerships necessary for the development of the Quality culture.

Lim Pey Chyi -

Recruitment Consultant (R )

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

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