About the role
- Is a member of the Quality Leadership Team responsible for the day to day management activities of the QC laboratory function on both the Hull and Nottingham manufacturing sites
- To standardise operations across both sites, to control and improve the analytical laboratories such that analysis is provided on time, Laboratory KPIs are met and that the laboratories remain in compliance with Good Laboratory Practice
- The Quality Control Department on each site comprises of teams dedicated to:
- Finished Product Testing
- Incoming Goods Testing
- Ongoing Stability Testing
- The laboratories support the manufacturing areas within the factory to ensure high levels of customer service are achieved and consistently maintained.
- The stability function supports our Quality Assurance obligations providing data to show our products remain compliant throughout their shelf life.
- This is a technical role which provides analytical information for routine manufacture, regulatory submissions, changes to existing products and new products introductions.
- Continuously evaluates new testing methods and seeks out opportunities for building in and validating process analytical testing in the manufacturing areas.
- Works closely with the QP on batch release issues if required
- Management of a team of QC analysts
- Ensure adequate resources to enable customer service levels to be routinely delivered
- Ensure compliance to international standards of GLP, Health safety and environmental, GMP
- Ensure out of specification results are thoroughly investigated and batch failures are escalated quickly to avoid customer service issues.
- Ensure stability out of specification results are thoroughly investigated and are escalated within the Quality function to avoid Regulatory Compliance issues.
- Manage systems for laboratory equipment , procedures, documentation and training
- Ensure NPD transfer and improvement projects are managed to project deadlines
- Continually improves, modifies laboratory work practices and procedures to standardise best practice across both manufacturing sites which will compliment a flexible factory
- Conducts internal and external quality audits as required
- Approves formulation specifications for existing and new products
- Responsible for people development within the QC laboratory teams
Technical/Professional Qualifications required
- Proven management experience in a similar role in the pharmaceutical or an associated industry
- Demonstrated people management skills
- Good understanding of pharmaceutical document systems
- Working knowledge of IT systems and their validation e.g. LIMS.
- Broad knowledge of pharmaceutical manufacturing processes including sterile products, solid and liquid dosage forms.
- Analytically capable, able to understand and resolve technical issues
- Qualified Chemist – Degree, and member of professional body.
- Project management skills
- Good communication, presentation and influencing skills.
- Ability to work with and influence cross functional teams in particular the regulatory team & Senior Manufacturing Operations Team.
- High attention to detail to identify areas where a system is not sufficiently robust but also be able to present a solution to improve the system.
- Be able to present a clear process flow and display ways in which improvements can be made with existing or new technology.
- Ability to develop others in an analytical environment that ultimately supports operational excellence in quality, cost and service vision of RB