Deputy Head of Quality & Qualified Person - Cheshire
Aim of this role is to find not only a qualified QP with the license to release products in mutiple dosage forms but also a leader with a personality and ability to drive change and help facilitate growth through qualify improvement and process efficiencies.
Satisfaction of this role will be the direct impact on the progression and growth of this company
If you are a Qualified QP Please contact us to discuss
Duties 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
Look forward to hearing from you
