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, recommending improvements where appropriate.
- Support the life cycle management of QC lab equipment, including qualification and periodic review for intended use.
- Decommission QC equipment and maintain an 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, resolving any quality control events, issues or discrepancies, and implement remediation actions from findings and CAPAs.
- Provide support during regulatory inspections and audits.
- Prepare metrics and monitoring data for qualification and validation activities, identifying 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 the QC excellence team.
- Support invalid assay trending program in the QC laboratory.
- Record all expected raw data, calculations, information related to duties to comply with cGMP and data integrity requirements.
- Perform tasks in accordance with cGMP, HSE requirements, and associated instructions, procedures, and records.
Requirements
- Minimum of two (2) years of experience in quality control within the pharmaceutical industry, with good knowledge of GMP and regulatory requirements, and hands‑on exposure to QC laboratory instruments and ALCM management.
- Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life sciences or technology.
- 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.
- Experience in analytical method continuous monitoring.
- Excellent interpersonal skills to establish partnerships necessary for the development of a quality culture.
Contact
Lim Pey Chyi – Apple.lim@manpower.com.sg
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423