Validation and Quality Assurance Specialist
6 days ago
About PM ASIA PROJECT SERVICES PTE. LTD.
We are a leading provider of project services in the Asia-Pacific region, specializing in commissioning, qualification, and validation work within the Life Sciences space.
Job Summary
We are currently seeking an experienced Validation and Quality Assurance Specialist to join our team. As a key member of our CQV team, you will be responsible for supporting our clients in the field of commissioning, qualification, and validation work.
Responsibilities- Qualification Activities: Plan, perform, and coordinate Computer System Validation, Equipment Qualification, Temperature Controlled Objects (Freezers, Incubators, etc.), Clean Utilities Validation, and cleaning validation in accordance with internal procedures and industry standards.
- Documentation Creation: Develop, review, and approve equipment qualification and analytical instruments lifecycle documentations, including FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
- Investigation Leadership: Lead investigations revolving around discrepancies identified during qualification activities.
- Experience: Relevant experience in validation activities, including creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents.
- Leadership: Proven ability to lead daily validation meetings with cross-functional teams to resolve validation issues.
- Equipment Qualification: Experience in equipment qualification, including analytical instrumentation and manufacturing equipment.
- Industry Knowledge: Work experience in Pharmaceutical or BioPharma industries.
- Validation Execution: Hands-on validation execution experience.
- cGMP Environment: Ability to execute activities in a cGMP environment, including cleanrooms or technical areas.
The salary for this role is estimated to be between SGD $80,000 - $120,000 per annum, depending on experience. In addition to a competitive salary, we offer a comprehensive benefits package, including medical insurance, retirement plan, and paid time off.
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