全职 QC System Specialist 工作, 薪水, Barrington James 公司招聘中 - Ricebowl

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 4,500 - SGD 7,000

Key Attributes/Responsibilities:

• Looking for candidates with 2+ 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