QA Validation Engineer- Cqv/csv

2 weeks ago

Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients.

We are currently looking for Junior QA Validation Engineer to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities:

- Manage day-to-day Quality Assurance activities in accordance with approved Project Plans and Policies for a fast paced brown field project.
- Review and Approve C&Q plans/protocols/report and GxP SOPs/records
- Provide quality oversight to quality and validate biopharmaceutical GMP plant in areas facilities, utilities and equipment, control systems, process and computerized system.
- 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 the qualification coordination meeting to ensure correct event sequence in compliance.
- **Must have experience in CQV in a pharmaceutical project

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