QA Validation Engineer - UK, Swindon - 3-6 Months Contract
Our client is a leader in helping address some of the world’s biggest science, health, and environmental challenges. The company works together to accelerate research, solve complex analytical challenges, improve patient diagnostics, drive laboratory productivity and produce life-saving treatments for patients. They are currently seeking aQA Validation Engineer for their Swindon based location.
Responsibilities:
* Review and assess commissioning, qualification, and validation documents for various equipment used in sterile pharmaceutical manufacturing.
* Ensure all documents comply with current Good Manufacturing Practices (cGMP), FDA regulations, and other relevant industry standards.
* Identify and document any discrepancies, gaps, or non-conformities in the CQV documents.
* Provide recommendations for corrective actions and improvements to ensure compliance and quality.
* Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to resolve issues and implement changes.
* Maintain accurate records of document reviews and ensure timely completion of tasks.
* Stay updated with the latest industry trends, regulations, and best practices related to CQV and sterile pharmaceutical manufacturing.
Requirements:
* In-depth knowledge of commissioning, qualification, and validation processes in Pharmaceutical Sterile Manufacturing.
* Familiarity with regulatory requirements such as FDA, EMA, and cGMP.
* Exceptional attention to detail and strong analytical skills.
* Excellent written and verbal communication skills.
* Ability to work independently and manage multiple tasks effectively.
* Proficiency in using document management systems and quality management software.
* Experience with risk-based approaches to validation
If this role is of interest to you, please apply now!
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