
Senior Qc/lab Equipment Validation
5 days ago
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.
This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.
We are currently looking for **QC/LAB Equipment Validation Engineers** to join us on a permanent basis to help us deliver various projects in the Life Sciences Industry.
Key Attributes/Responsibilities:
- 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, etc).
- 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
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