QC Associate

2 weeks ago

Singapore Manpower Singapore Full time

QC Associate – Equipment Qualification & System Support This role is offered by Manpower Singapore. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base Pay Range Location: Gul Circle Salary: Up to SGD 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 by protecting more people and offering hope to patients and their families. Responsibilities Update 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 – qualification of QC equipment and periodic review to maintain intended use. Decommission QC equipment and maintain up‐to‐date lab equipment inventory. Participate in documentation issuance and review of qualification and maintenance deliverables (risk assessments, traceability matrices, protocols, reports, deviations, and summary reports). Support laboratory qualification investigation and resolve quality control events, issues or discrepancies. Implement remediation from findings and CAPAs. Provide support during regulatory inspections and audits. Prepare metrics and monitoring data for qualification and validation activities, 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, and related information to comply with cGMP and data integrity requirements. Perform tasks in accordance with cGMP and HSE requirements and related procedures, instructions, records. Requirements Minimum of two years' 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/technology. 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. Understanding of good laboratory practices, good documentation practice and data integrity requirements. Experience in continuous monitoring of analytical methods. Excellent interpersonal relationships to establish partnerships necessary for developing a culture of quality. Contact : Lim Pey Chyi – (Recruitment Consultant)#J-18808-Ljbffr

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