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