QA Operations Engineer
1 day 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 a Quality Assuarance engineer for an operations support project to join us on a permanent role to help us deliver various projects in the Life Sciences Industry.
**Key Attributes/Responsibilities**
- Enhance proficiency in the QA Change Control process and relevant tools, facilitating training sessions for change users when necessary.
- Ensure compliance with Change Control management systems and procedures.
- Assess Change Control requests for process adherence, validation, regulatory compliance, and product impact.
- Manage the review and approval of change requests to ensure prompt implementation.
- Oversee the management of all site changes to align with the expectations of the global change control board (if applicable) and meet site project deadlines.
- Participate in cross-functional and cross-site change management discussions.
- Work collaboratively with departments to streamline and optimize change control activities, providing support to stakeholders throughout the process.
- Ensure that all necessary change control actions are completed before lifting lot disposition restrictions.
- Review Change Records to support Annual Product Review activities.
- Maintain and enhance change control processes for continuous improvement.
- Assist in regulatory inspections and provide audit support, including presentations and review of facility, utility, and equipment documentation with your team.
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