R&D QA Manager / QP - Cheshire - Pharma/Medical Devices
Salary: Circa 75k
Purpose of Role
To lead the R&D Quality Team to provide oversight and support to the New Product Development and Technical Support functions to ensure that new products are developed and projects and processes are introduced to the respective manufacturing site in compliance with current Good Manufacturing Practices. To act as a Qualified Person under EU directives for Investigational Medicinal Products.
Key Results Areas
- 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.
Knowledge, Skills and Competencies
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 steriles 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.
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.
QP / QUALIFIED PERSON / QA MANAGER / HEAD OF QA / QC MANAGER / MANAGERIAL / TECH TRANSFER / TECHNOLOGY TRANSFR / DRUG DELIVERY / INJECTABLES / STERILES / STERILITY / COMBINATION DEVICES / MEDICAL DEVICES / PHARMA / PHARMACEUTICALS / GMP / ENGINEERING / MANUFACTURING / PROTOTYPE / MANUFACTURING / PRODUCTION / REGUALTORY / CLINICAL / COMPLIANCE / R&D / PRODUCT DEVELOPMENT / DESIGN / ENGINEER / SCIENTIST / CHESHIRE / CHESTER / DERBY / DERBYSHIRE / MANCHESTER / LANCASHIRE / LANCASTER / LIVERPOOL / NORTH WALES / UK / UNITED KINGDOM / RELOCATE / GSK / GLAXO / BESPAK / ASTRA ZENECA / NOVARTIS / QAIGEN / PFIZER / SANOFI / PRODUCT DEVELOPMENT / ENGINEER / ENGINEERING / CLINICAL / REMEDIATION / PACKAGING / SCIENTIST / SCIENTIFIC / BIOMEDICAL / MEDICAL / HEALTHCARE / REGULATORY AFFAIRS / QA / QUALITY ASSURANCE / FORMULATION / AUDITING
- Medical Devices
- sterile products
- Drug-Device Combination Products
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