QC Associate

2 weeks ago

Singapur, Singapore Manpower Singapore Full time

QC Associate - Equipment Qualification & System Support 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. Supporting periodic analytical method control trend reviews/investigations and data evaluation on method performance; recommending method improvements where appropriate. Supporting the life cycle management of QC lab equipment, including qualification of QC equipment and periodic reviews to maintain their intended use. Decommissioning QC equipment and maintaining up-to-date lab equipment inventory. Participating in the issuance and review of qualification and maintenance deliverables, such as risk assessments, traceability matrices, protocols, reports, deviations, and summary reports. Supporting laboratory qualification investigations and resolving any quality control events, issues, or discrepancies within their perimeter; implementing remediation actions from findings and CAPAs. Providing support during regulatory inspections and audits. Preparing metrics and monitoring data for qualification and validation activities to identify trends and issues during the lifecycle management of QC laboratory equipment. Supporting initiatives for continuous improvement in QC support processes related to lab equipment management in coordination with the QC excellence team. Supporting the invalid assay trending program in the QC laboratory. Recording all expected raw data, calculations, and related information to comply with cGMP and data integrity requirements. Performing tasks in accordance with cGMP and HSE requirements and with the associated instructions and procedures. Requirements Minimum of two (2) years of experience in quality control within the pharmaceutical industry, including good knowledge of 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. Strong understanding of good laboratory practices, good documentation practice, and data integrity requirements. Experience in analytical method continuous monitoring requirements. Excellent interpersonal relationships to support the development of a quality culture. For inquiries, please contact Lim Pey Chyi at Seniority level: Associate Employment type: Contract Job function: Quality Assurance and Science • Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr

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