QA Operations Engineer

4 days 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 the 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 have been key to our success to date.

We are currently looking for a QA Ops Engineer to join us in a permanent role to help us deliver various projects in the Life Sciences Industry.

**Key Attributes/Responsibilities**:
1. Guarantee compliance with the systems and procedures of Change Control management.

2. Build expertise in the QA Change Control process and associated tools, facilitating training for change users when necessary.

3. Assess Change Control requests for impacts on process, validation, regulations, and products.

4. Manage the review and approval process of change requests to ensure timely implementation.

5. Ensure that all site changes align with the global change control board's expectations (if applicable) and adhere to site project timelines.

6. Actively participate in cross-functional and cross-site change management forums.

7. Collaborate with departments to streamline and enhance the execution of change control activities, providing support to stakeholders throughout the process.

8. Verify the completion of necessary change control actions before removing lot disposition restrictions.

10. Conduct reviews of Change Records to support Annual Product Review activities.

11. Maintain and continually improve change control systems and processes.

12. Provide support for regulatory inspections, including assistance with audits, presentations, and reviewing documentation related to facilities, utilities, and equipment


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