QC Associate

2 days ago

Singapore Manpower Singapore Full time

Description QC Associate – Equipment Qualification & System Support 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. Location: Gul Circle Salary: Up to $7,000 depending on experience Contract: 12-Months Contract 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 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 resolve any quality control events, issues or discrepancies from his/her perimeter. Implement remediation actions from findings and CAPAs. Provide 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. Record all expected raw data, calculations, information related to his/her tasks to comply with cGMP and data integrity requirements. Perform tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, 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 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. Experience in analytical method continuous monitoring requirements. Excellent interpersonal relationships to establish the partnerships necessary for the development of the Quality culture. Senior­ity level: Associate Employment type: Contract Job function: Quality Assurance and Science Industry: Pharmaceutical Manufacturing Contact: Lim Pey Chyi – #J-18808-Ljbffr Industry Other Category IT & Technology Sub Category Technical Support & Administration

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