QA Validation Engineer
Posted 5 days ago by QCS Staffing
Negotiable
Undetermined
Undetermined
Swindon, England, United Kingdom
Summary: The QA Validation Engineer role in Swindon involves reviewing and assessing commissioning, qualification, and validation documents for equipment used in sterile pharmaceutical manufacturing. The position requires ensuring compliance with regulatory standards and collaborating with cross-functional teams to resolve issues. The engineer will also maintain accurate records and stay updated on industry trends. This is a contract position lasting 3-6 months.
Key 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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: Swindon
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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 a QA 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!