QA Validation Engineer - Sterile Pharma

Driver Hire Borders; Swindon; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading company in sterile pharmaceutical manufacturing is seeking a meticulous QA Validation Engineer for a contract role in Swindon. The successful candidate will conduct thorough reviews of CQV documents, ensuring compliance with strict industry standards and contributing to the maintenance of quality in a dynamic environment.

Qualifications

• In-depth knowledge of CQV processes in Pharmaceutical Sterile Manufacturing.
• Strong familiarity with FDA, EMA, and cGMP regulatory requirements.
• Experience with risk-based approaches to validation is a significant plus.

Responsibilities

• Review and assess commissioning, qualification, and validation documents.
• Ensure documentation complies with cGMP, FDA regulations, and industry standards.
• Provide recommendations for corrective actions to maintain compliance.

Skills

Attention to Detail

Analytical Skills

Communication

Documentation Management

Tools

Quality Management Software

Document Management Systems

Job description

Contract QA Validation Engineer - Sterile Pharma (Swindon)

£55-£65 per hour | 3-6 Month Contract (Potential Extension)

Are you a meticulous QA Validation Engineer with a strong background in sterile pharmaceutical manufacturing? We're seeking an experienced contractor to join our team in Swindon as a Document Reviewer for Commissioning, Qualification, and Validation (CQV) activities. This is an excellent opportunity to apply your expertise in a critical role, ensuring compliance and quality in a dynamic environment.

About the Role:

As a key member of our team, you'll be responsible for the comprehensive review and assessment of CQV documents for a range of equipment used in sterile pharmaceutical manufacturing. Your sharp eye for detail will be crucial in identifying discrepancies and ensuring all documentation adheres to the highest industry standards.

What You'll Be Doing:

• Thoroughly review and assess commissioning, qualification, and validation documents for various sterile pharmaceutical manufacturing equipment.
• Ensure all documentation strictly complies with cGMP, FDA regulations, and other relevant industry standards.
• Proactively identify and document any discrepancies, gaps, or non-conformities within CQV documents.
• Provide clear, actionable recommendations for corrective actions and improvements to maintain compliance and quality.
• Collaborate effectively with cross-functional teams, including engineering, quality assurance, and operations, to resolve issues and implement necessary changes.
• Maintain accurate records of all document reviews and ensure tasks are completed on time.
• Stay up-to-date with the latest industry trends, regulations, and best practices in CQV and sterile pharmaceutical manufacturing.

What We're Looking For:

• In-depth knowledge of commissioning, qualification, and validation processes specifically within Pharmaceutical Sterile Manufacturing.
• Strong familiarity with regulatory requirements such as FDA, EMA, and cGMP.
• Exceptional attention to detail and robust analytical skills.
• Excellent written and verbal communication abilities.
• The ability to work independently and efficiently manage multiple tasks.
• Proficiency in using document management systems and quality management software.
• Experience with risk-based approaches to validation is a significant plus.

Ready to make an impact? If you're a dedicated QA Validation professional looking for an engaging contract opportunity, we want to hear from you! Apply now

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.