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Quality Assurance and Compliance Engineer

Quality Assurance and Compliance Engineer

Title: Quality Assurance and Compliance Engineer
Reporting to: Production Engineering & Supply Chain Manager
Location: Office-based, Warwick


Introduction
Quality is foremost in everything we do at 3P innovation, and as part of our current expansion plans the Quality Assurance and Compliance Engineer role is essential in enabling us to continue to deliver a first-class experience to our customers.

The role will give you the opportunity to bolster the company’s existing Quality Management System and infrastructure, while leading quality activities to assure process compliance with company standards and cGMP requirements, in accordance with current legislation. You will be responsible for continually driving 3P’s quality performance to ensure that all stakeholder expectations are exceeded.

Based in our Warwick facility, you will also be involved in the quality control of our Pharma production equipment, whilst having direct contact with our customers and suppliers, forging long term partnerships to better understand and resolve their technical issues.


Key Responsibilities
• To be the independent, data driven, technical conscience of the organisation.

• Provide quality oversight and guidance for 3P’s activities, ensuring compliance to regulatory requirements, process/standards.

• Quality review and approval of technical documents to ensure requirements are met.

• Lead full independent peer reviews/non-advocate reviews and lessons learnt activities as required.

• Management and optimisation of 3P’s quality management system, ensuring its integrity is maintained.

• Own and maintain the CAPA process.

• Conduct routine quality management reviews with project teams and management.

• Assure execution of internal audit programme across business process areas.

• Maintain ISO 9001 certification status, leading the annual external audit. Attainment of ISO14001.

• Establish procedures and methods to comply with applicable cGMP, ISO requirements and customer expectations.

• Support collection, monitoring and analysis of quality performance indicators using quality standards and tools in place to evaluate the effectiveness of the Quality System.

• Identify, lead and/or support implementation of continuous improvement opportunities.

• Assure the proper use of change management associated with validated processes.

• Implement and manage a cross-functional risk assessment programme.

• Monitor and develop the quality performance of 3P’s supply base.

• Build and maintain trusting relationships with external partners whereby influence can be applied and accepted to ensure that 3P’s quality standards are continually met.

• Quality control of 3P’s manufactured products.

• Provide quality process training where needed.

 

Essential skills/attributes

• Excellent command skills, a positive outlook to problem resolution, with the ability to depersonalise audit reviews.

• Lead by example, coaching with a balanced constructive question and challenge capability.

• Batchelor degree qualified in manufacturing, engineering or science discipline.

• 2+ years’ experience working in a technical engineering role in a manufacturing organisation.

• Experience working within a 9001 quality management system.

• Exceptional organisational skills with ability to help the team grow and thrive.

• Experience with customer interface and meeting customer expectations.

• Demonstrate commercial awareness when implementing systems and processes.

 

Desirable Skills/attributes

• 5+ years’ experience working in the quality function in an engineering and manufacturing organisation/highly regulated industry.

• Working knowledge of ISO requirements (9001/14001/IATF16949) or pharmaceutical industry requirements (cGMP, etc).

• Experience in managing a Quality Management System.

• Working knowledge of pharmaceutical processes, analytical testing, method development and validation.

• Highly experienced in generation and use of quality management tools such as PFMEA, control plans, CCAR, RCA etc.

• Experienced in supplier quality management and development.

• Experienced in undertaking internal and external audits.

• Working familiarity with project management tools and quality risk management.

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