About our client: Our client is a leading global pharmaceutical company.
About the role:
- Responsible for commissioning, qualification, and validation activities for analytical and QC laboratory equipment to ensure compliance with GMP requirements, regulatory standards, and company procedures.
- Develop and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Perform commissioning and qualification activities for analytical/QC laboratory equipment such as HPLC/UHPLC, Gas Chromatography (GC), UV-Vis Spectrophotometers, TOC Analysers, Dissolution Systems, pH & Conductivity Meters, Balances, Laboratory Incubators, Ovens, and Refrigerators.
- Prepare and review qualification documents, risk assessments, validation protocols, and summary reports.
- Support FAT (Factory Acceptance Test), SAT (Site Acceptance Test), calibration, and vendor management activities.
- Perform temperature mapping activities and support equipment qualification lifecycle activities.
- Manage deviations, CAPAs, and change controls to ensure timely resolution and compliance.
- Ensure complete traceability from User Requirement Specifications (URS) through qualification testing and documentation.
- Support integration and verification of laboratory systems including LIMS, CDS, PCS, MES, and OSI PI Historian.
- Verify data integrity requirements including audit trails, user account management, security roles, electronic signatures, backup and restore functionality, and time synchronization.
- Collaborate with QA, QC, Engineering, Automation, IT teams, and vendors to ensure successful execution of qualification activities.
About you:
- Bachelor's Degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or related discipline.
- Minimum 5 years of experience in Commissioning, Qualification & Validation (CQV) activities for analytical and QC laboratory equipment within pharmaceutical, biotechnology, or GMP-regulated environments.
- Strong understanding of GMP requirements, Data Integrity principles (ALCOA+), and qualification lifecycle processes.
- Hands-on experience in executing IQ/OQ/PQ protocols and managing qualification documentation.
- Experience in risk assessments, deviation management, change controls, and validation reporting.
- Familiarity with chromatography data systems such as Empower or Chromeleon and knowledge of Computer System Validation (CSV) requirements will be advantageous.
- Knowledge of regulatory requirements including FDA, EU GMP, and PIC/S guidelines is preferred.
- Strong technical writing and documentation skills with good analytical and problem-solving abilities.
- Excellent communication, stakeholder management, and coordination skills.
- Strong attention to detail with a proactive approach and ability to work independently in a cross-functional environment.
Other:
- Employment Type: Contract
- Work Schedule: 5 days per week
- Location: Tuas, Singapore
.Please note that only shortlisted candidates will be contacted..
Employment Agency: Kingsforce Management Services Pte. Ltd.
Employment Agency Licence No: 94C3545
EA Personnel: Kimberly Wong
EA Personnel Reg. No.: R1984508
