We are currently looking for QC System Specialist for one of my Global Pharmaceutical MNC client on a long term contract. This is an exciting opportunity to join a huge MNC in a huge brownfield project.
Role: QC System Specialist
Location: Singapore, Tuas
Type: 12 months contract (extendable)
Salary: SGD 6,000 - SGD 8,000
Key Attributes/Responsibilities:
- Looking for candidates with 5+ years QC/Lab Equipment Validation experience.
- Provide technical support to run and validate necessary test methods on lab equipment and in developing method transfer/validation protocols and reports.
- Perform qualification and validation for in process, release and stability equipment (HPLC, UV, TOC, pH, GC etc).
- Conduct thermal mapping and temperature uniformity studies of laboratory temperature-controlled equipment (e.g., refrigerators, freezers, incubators, ovens) to ensure compliance with regulatory and quality standards
- Manage day-to-day Quality Control/LAB Validation activities in accordance with approved Project Plans and Policies for a fast-paced brownfield project.
- Help with lab system validation, develop and oversea system qualification
- Review and Approve C&Q plans/protocols/reports and GxP SOPs/records
- Review validation life-cycle documents during the commissioning, qualification (IQ/OQ), and validation (PQ) phase e.g., pre and post-execution commissioning/ qualification plans and test specifications, validation summary reports & etc.
- Ensure that documents are in compliance with quality standards and applicable regulatory requirements
- Review engineering change control to evaluate the validation/quality impact(s).
- Support in the resolution of validation deviations and approval.
- Participate in the qualification coordination meeting to ensure correct event sequence in compliance
