R&D QA Manager
£80,000 + Excellent benefits
gap technical are proud to be representing this global manufacturing business in their search for a R&D QA Manager to work at their facility based near Warrington.
- To monitor activities within the Generic R & D (New Product Development) Department and where appropriate, Technical Support functions to ensure that current Good Manufacturing Practices, Global Policies and Standards and relevant Regulatory Authority requirements are met.
- To review and approve all documentation generated in support of new products and processes to ensure compliance with regulatory requirements.
- To assess current and developing regulations and regulatory position in order to develop and implement changes within the business to ensure continued compliance.
- To contribute to the development of quality policy and awareness as applicable to R&D at the Runcorn site. To monitor and update the Quality System for R&D on site to ensure continued compliance.
- To support technical transfer and training of staff to ensure that robust products are transferred to operations.
- Act as lead QP for the release of Investigational Medicinal Products.
- Act as lead Quality representative for Regulatory inspections for new product approvals (i.e. Pre-Approval Inspections, Bioequivalence inspections).
- Ensure that the NPD QA team provide audit expertise to the NPD vendor assurance programme.
- Lead and coach the NPD QA Team to ensure they have the appropriate knowledge and skills to undertake their role to the highest possible standard.
Minimum Qualifications/ Experience
- Must have a degree in a relevant science discipline.
- Qualified Person under EU directive, eligible to release Investigative Medicinal Products.
- Previous experience in a Quality Leadership role with previous experience operating as a Quality Assurance Manager in a modern manufacturing/R&D environment within the pharmaceutical industry.
- Experience in sterile operations to EU and FDA standards.
- Experience of new product introduction from development to final approval.
- Experience with reviewing and assessing the suitability of new product licence dossiers/ submissions.
- Experience with Regulatory inspections (either hosting or being a key presenter).
- Knowledge base expected of a QP, with special emphasis on the development and manufacture of sterile products.
- Good communicator with the ability to set and deliver high standards relating to quality, safety, cost and customer service. Ability to influence at all levels of the Organization.
- Strong leadership skills with the ability to influence standards of behaviour and ways of working which contribute towards compliant and on time NPD operations.
- Ability to objectively review a wide range of technical data and feed back problems and concerns in a constructive manner.
- Ability to present information to and influence external auditors.
- Ability to coach, train and develop team members.
Please send your CV and call Charlotte at gap technical on 01925 406 525
If you have any questions or are interested in any other opportunities we may have, please do not hesitate to contact on 01925 406 525
This vacancy is being advertised on behalf of gap technical who are operating as an employment agency.
gap technical are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job.
Closing Date: 17/10/2018
Up to £80000 per annum
Job Start Date:
Days Only (Mon-Fri)