Senior Csv Quality Assurance Engineer

3 days ago

Singapore COMBUILDER PTE LTD Full time

**Responsibilities**:

- Supervise the day-to-day Quality Assurance activities in accordance with approved Project Plans and Policies for fast-paced green field and/or brown field project.
- Develop and execute quality assurance & validation protocols for GMP plant & systems in the areas such as facilities, utilities and equipment, control systems, process and computerized system, ensuring they meet regulatory requirements and compliance with local, EU, UK and FDA GxP regulatory requirements and any other applicable regulations/standards.
- Collaborate with cross-functional teams to ensure system compliance and validation throughout the project lifecycle. Ensure all equipment, facilities, and systems are validated and compliant with regulatory requirements.
- Lead the qualification coordination meeting to ensure correct event sequence in compliance.
- Review and Approve C&Q plans/protocols/report 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.
- Conduct risk assessments and develop mitigation strategies.
- Maintain detailed documentation of validation activities and ensure all records are audit-ready. 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.

**Requirements**:

- Master or Bachelor degree in an Engineering, Scientific or Technical discipline.
- Minimum 5 years’ experience working predominantly in Engineering Validation department with emphasis on Computer System Validation execution and Validation activities across manufacturing, laboratories and facilities.
- In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES.
- Excellent practical Knowledge of GxP regulations and guidelines with regards to validation and qualification, ensuring compliance with local, EU, UK and FDA GxP regulatory requirements and any other applicable regulations/standards.
- A working knowledge and practical experience with validation protocols, risk assessments, and regulatory compliance.
- Certified or highly skilled in Six Sigma methodology.
- Strong proficiency in SAP and other enterprise systems.
- Familiarity with tools like Trackwise, Kneat, or similar validation/documentation platforms.
- Previous experience supporting both clinical and commercial manufacturing environments is a plus.

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