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 - Apple.lim@manpower.com.sg
Recruitment Consultant (R2090579) — Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
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