Quality Manager

IPS (Part of the Culina Group) works with some of the best known brands and provides cost effective and innovative co-packing, co-filling and co-manufacturing solutions within the UK.

At Culina we have a winning culture, we believe that our culture is one of the reasons our company continues to thrive… A place where you're valued, challenged, and inspired!

As a Quality Manager you will be responsible for managing the Compliance and H&S department and ensuring the overall GDP compliance of the site.

You will have a key responsibility in maintaining and developing all aspects of compliance management and Health & Safety profile of the site.

Carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate compliance with EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) and all relevant legislations (COMAH, EU Medical Devices Directive 93 / 42 / EEC etc.)

• Named as the primary Responsible Person on the WDA(H) and Controlled Drug licence
• Maintain and continually improve the company’s Quality Management System in compliance with current MHRA GDP guidelines, applicable certifications and group policies and procedures.
• Responsible for the generation, revision, approval of procedures and other GDP documents
• Responsible for creation of annual audit programme, performance of RP audits and management of self-inspections.
• Ensure that any subcontracted activities which may impact on GDP are approved
• Act as the lead contact for MHRA, client and corporate audits
• Responsible for creation and review of Technical Agreements
• CAPA and NCR management. Responsible for management of the investigation and resolution of operational discrepancies and customer complaints having final approval of outcome.
• Review and approve validation protocols and ensure that all systems are validated
• Decide on the final disposition of returned, rejected or falsified products
• Coordinate and promptly perform any product recall operations
• Management of risk assessment programme and ensure that the mitigation strategies are defined and implemented
• Responsible for change management. Ensure that change control process in place for documentation, processes and systems
• Oversee sampling and quality assurance release of products