My client, a leading pharmaceutical manufacturing organisation are looking for an Operations Quality Director. It’s a great opportunity to join a site that has undergone a recent restructure and has big investment plans.
Title: Quality Director
Location: North East
- Build and manage a team of Qualified Persons responsible for supporting the GMP-compliant production
- Perform regular Product Quality Reviews as outlined in Eudralex Annex 16 and Vol. 4
- Oversee and manage the Operational Quality Assurance team (‘Quality on the shop floor’) which provides QA support for all manufacturing activities (e.g. issuing and reviewing worksheets, labels, forms, raising deviations related to the manufacturing process).
- Facilitate innovation and continual improvement of the product throughout its lifecycle.
- In conjunction with the Site Quality Head and other relevant company members, ensure that relevant facilities, systems and processes are suitably documented and compliant with GMP.
- Support the qualification and maintenance of premises and equipment.
- Ensure that the appropriate validations are conducted.
- With Head of Process Development, advise on development decisions as they relate to QbD and other early lifecycle considerations
- Act as the lead Qualified Person in line with Articles 49 and 51 of Directive 2001/83/EC and Annex 16 of EurdaLex Volume 4
- Review and approve specifications, sampling instructions, test methods and other Quality Control procedures, as required
- Author and review internal company reports and regulatory documentation, as required
- Lead audits and represent the company as required
- Advise the senior management team on relevant Quality issues and resource needs
- Be an active member of the Site Quality Team and advise the Senior Leadership Team on QP topics, if required
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