Quality Engineer

Reporting to: Quality Manager

Primary Objective:

Provide support to the Quality team at Central Pharma, Central Pharma is a company that provides manufacturing, filling and packing, specialist storage and logistics, regulatory support, serialisation, and technology services to the pharmaceutical, medical device, cell & gene, and healthcare industries.

Role Responsibilities:

• Support the Quality Assurance and Quality Control functions, to enable the delivery of first-class support and QA oversight across the sites to ensure that all activities are carried out in a GMP compliant manner.
• Maintain and continuously improve the Quality Management Systems within Central Pharma supporting Calibration, CAPA, Complaint investigations
• Provide trending data and reports upon request to senior management, functional managers, regulatory authorities, and customers
• Train, motivate and develop both team and individual performance.
• Develop training materials for design and manufacturing teams with respect to IQ/OQ/PQ validation requirements.
• Assist with validation plans for new tools, machines, and processes.
• Work towards meeting departmental and facility objectives.
• Participate in facility internal and external audits as required.
• Development of cross-functional and collaborative relationships within the facility.
• Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business.

Required Skills and Experience:

• Qualified to Degree level or equivalent in Science and be a member of the appropriate professional body
• Have experience in MHRA inspections.
• Have significant experience in a modern manufacturing environment within the pharmaceutical industry.
• Have a comprehensive understanding of Cleanroom controls, EU regulatory guidelines and the product licensing processes, GMP/GDP requirements, Quality Management systems and the principles of risk management as defined in ICH Q9 and its practical application in a manufacturing and/or packing environment.