Deputy Head of QA & QP
A leading pharmaceutical company, developing and manufacturing respiratory medicines, is currently recruiting a Deputy Head of QA & QP based in the UK.
- Ensuring the batch release process is fit for purpose and satisfies the requirements of Eudralex Volume 4 Annex 16.
- Ensuring governance structures across the site is 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 the 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.
- Ensuring an effective Supplier Quality programme is in place to meet the requirements of GMP within the various supply chains the company are party to, and assure only materials, equipment or individuals of appropriate quality are used at the company.
- Promoting a strong quality culture throughout the site.
- Providing guidance and advice to departments across the site to assure effective and compliant performance in the manufacture and testing of pharmaceuticals.
- Ensuring clear and effective communications to clients with regard batch disposition, deviation investigation, process change or improvement.
- Promoting technical expertise and effective understanding of processes to underpin risk management principles.
- Supporting trending, governance and reporting of key process and quality indicators across the site.
- Promoting effective review, interpretation and application of process and quality data in decision making across the site.
- Helping 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.
Skill and Requirements:
- 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 the 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.
- Responsibility for own area for H&S, along with all other employees and managers.
- Report and document any known accidents, or near misses, by report form.
- Maintain a flexible and adaptable approach to work, tasks and demands at all times.
- Participate in other duties outside the normal area of work within the capabilities of the individual.
- Willingness to assist with other sites within the group.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 203 854 3317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.