QC Specialist

2 weeks ago

Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full time

Overview QC Specialist – Analytical Methods, GxP Lab Equipment & LIMS (Pharma)Salary Up to $7,000 depending on experience Location : Tuas Industry : Pharmaceutical Our client is a global leader in the pharmaceutical industry, producing and delivering over 4 billion units of medicines and vaccines each year—making a real difference in getting life-saving treatments to those who need them most. They are driving the future of healthcare with state-of-the-art facilities, AI-powered smart factories, and cutting-edge automation, ensuring medicines reach patients faster, safer, and more sustainably. Responsibilities Represent the site in global Communities of Practice (CoPs) and Centers of Excellence (CoEs) for QC processes and ensure effective local communication. Maintain the site Validation Master Plan and procedures related to Analytical Lifecycle Management (ALCM) and Continued Process Verification (CPV) for GxP laboratory equipment. Oversee lifecycle management, qualification, and maintenance of QC lab equipment, ensuring compliance with regulatory and quality standards. Lead and support analytical method lifecycle activities including method reviews, trending, data evaluation, and compendial compliance. Drive implementation and maintenance of QC digital solutions (e.g., LIMS), including data integrity and end-user management. Support and investigate quality control events, deviations, and CAPAs within the QC scope. Coordinate documentation, review, and approval of qualification deliverables (e.g., risk assessments, protocols, reports). Provide technical leadership in analytical validation, method transfers, and lab projects. Act as SME for laboratory computerized systems and provide system administrator support. Support regulatory inspections and customer audits by presenting relevant documentation and records. Ensure safe laboratory operations and compliance with HSE and cGMP requirements. Deputize for QC Manager as required. Qualifications Ideally 5 years of experience in quality control within pharmaceutical with knowledge of Good Manufacturing Practices (GMP), regulatory requirements and expertise on lab instruments. Excellent interpersonal relationships to establish the partnerships necessary for the development of the Quality culture. Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements. Knowledge of the quality systems and associated technologies. Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement. 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. Experienced in analytical method continuous monitoring requirements. Lim Pey Chyi - Recruitment Consultant (R )Manpower Staffing Services (S) Pte Ltd EA Licence: 02C3423#J-18808-Ljbffr

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