QA Validation Engineer

Quanta Consultancy Services Ltd; Swindon; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading company in science and health solutions is seeking a QA Validation Engineer for a contract role in Swindon. The position entails reviewing validation documents, ensuring compliance with standards like cGMP and FDA, and collaborating with teams to improve processes. Ideal candidates will possess strong analytical skills, attention to detail, and relevant experience in the pharmaceutical industry.

Qualifications

• In-depth knowledge of commissioning, qualification, and validation processes in Pharmaceutical Sterile Manufacturing.
• Familiarity with regulatory requirements such as FDA, EMA, and cGMP.
• Experience with risk-based approaches to validation.

Responsibilities

• Review and assess commissioning, qualification, and validation documents for equipment in sterile pharmaceutical manufacturing.
• Ensure compliance with FDA regulations and other industry standards.
• Identify and document discrepancies in CQV documents.

Skills

Attention to detail

Analytical skills

Communication

Tools

Document management systems

Quality management software

Job description

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!

#LI-CB1