Deputy Head of Quality
- Experience Level
Leading Pharmaceutical Manufacturer based in Cheshire seeks an experienced Deputy Head of Quality / QP.
About the role:
- The role holder will primarily support the management of the Quality department and undertake the role and duties of QP in supporting the release of pharmaceutical products manufactured.
- The role holder will demonstrate leadership across site to support a sustainable quality culture.
- The role holder will deputise for the Head of Quality and will interact with senior members of staff at site.
- The role will be customer facing and will be engaged in stakeholder management.
- The role holder will be engaged in the direction of work within the QA team and in the support, training and mentorship of members of staff across site.
Duties may include:
- Roles and responsibilities of the Qualified Person as required by article 51 of directive 2001/83/EC and further detailed in Eudralex Volume 4 Annex 16
- Ensuring the batch release process is fit for purpose and satisfies the requirements of Eudralex Volume 4 Annex 16
- Ensuring governance structures across site are suitable to allow for certification of batch manufacture as required by article 51 of directive 2001/83/EC.
- Ensuring effective communication of key quality performance indicators to site leadership and site departments to support management of the site.
- Ensuring an appropriate Product Quality Review programme is in place to support continual review and understanding of the manufacturing process and promote continual improvement.
- Ensure an effective Supplier Quality programme is in place to meet the requirements of GMP within the various supply chains are party to, and assure only materials, equipment or individuals of appropriate quality are used.
- Promoting a strong quality culture throughout the site
- Supporting the development, training and mentorship of members of the QA team
- Providing guidance and advice to departments across site to assure effective and compliant performance in manufacture and testing of pharmaceuticals.
- Ensuring clear and effective communications to clients with regard batch disposition, deviation investigation, process change or improvement.
- Promote technical expertise and effective understanding of processes to underpin risk management principles.
- Support trending, governance and reporting of key process and quality indicators across site.
- Promote effective review, interpretation and application of process and quality data in decision making across site.
- Help conceive, define and deliver Quality related improvements projects.
- Any other activity deemed quality related by the Head of Quality.
- Roles and responsibilities of the Qualified Person as required by article 51 of directive 2001/83/EC and further detailed in Eudralex Volume 4 Annex 16.
Skills and experience:
- Eligible to act as a Qualified Person under the provisions of directive 2001/83/EC
- Experience within management and leadership roles within a Quality organisation
- Experience working in cross functional roles within a pharmaceutical manufacturing organisation
- Experience in roles with significant stakeholder or client interaction and influencing
- Experience in supply chain assessment and supplier auditing
- Good communication skills, and ability to influence and direct others
- QA Department internal performance KPIs
- Quality Management Systems performance (CAPA's, deviations, and complaints)
- Right first time figure at QP certification
- Regulatory Inspection performance
- Customer Audit performance
Apply for Deputy Head of Quality
Already uploaded your CV? Sign in to apply instantly