We are hiring for a QC Team Leader-GMP for our client based in Bristol to join their QC and Development team. They have been working within small molecule manufacture for over 30 years and are part of a multi-national company with a global footprint. The company is currently moving into a more diverse market and as such this is an exciting time to get on board.
What you’ll do:
Responsible for overseeing the day to day running of the QC team focused on the GMP product pipeline. Will have direct line management of a team of 2-4 analysts. Reporting to the Operations Director, they will be responsible for managing the delivery and execution of raw materials and product testing, including stability testing as part of the cGMP produced product portfolio.
Key responsibilities for the QC Team Leader in GMP role:
- To ensure that GMP is implemented correctly and adhered to.
- Implement, develop, and manage the cGMP processes within the QC GMP team.
- Development of analytical test methods in accordance with regulatory and company requirements.
- Take responsibility for fronting internal and external QC audits and dealing with out of specification (OOS) results should they arise within QC.
- Completing analytical projects and producing reports to meet agreed deadlines.
- To check and sign off results.
- To be able to arrange service, maintenance, validation, and calibration of equipment.
- To lead and develop staff within the team to reach the required performance and competency levels.
- To build and maintain key relationships within not only the QC GMP team, but also key areas such as the wider QC team, QA, Chemistry, Facilities and Supply Chain teams.
- Ensure the highest standard of scientific rigor and documentation is maintained.
- Work in a safe, tidy and responsible manner, abiding by relevant regulations.
For the QC Team Leader in GMP role:
Minimum requirements for the QC Team Leader in GMP role:
- Degree in chemistry, pharmaceutical Sciences or related in combination with a significant amount of related post-qualification experience.
- Extensive knowledge of GMP, ICH guidelines, BP/EP/USP methods and a strong understanding of QA processes and methodology.
- Strong, hands on experience of wide range of analytical techniques, especially but not limited to HPLC/UHPLC, LCMS, GC and managing stability testing.
- Strong commercial and scientific acumen coupled with report writing skills.
- Sustained high level of performance and productivity.
- Possess excellent verbal and written communication skills.
- Highly developed judgement and problem-solving skills, with ability to independently apply effective decisions to projects of diverse scope.
- Have a thorough grasp of the principles and required standards of H&S.
Specific competencies for the QC Team Leader in GMP role:
- Excellent communication skills with the ability to create solutions and communicate outcomes effectively with different audiences, doing so with tact and diplomacy.
- Strong team player with demonstrable ability to establish effective collaborative and operational relationships with cross-functional teams in the company, and with external contacts and customers as appropriate.
- Able to work to deadlines in a positive, flexible and pro-active way, placing a high priority on understanding and delivering on client needs.
- Self-motivated, can work independently, lead, influence and mentor scientific staff.
- Excellent organizational, time management, problem solving and trouble shooting skills.
- Ability to engage respectfully with the views of others.
Salary range for the QC Team Leader in GMP role is flexible and will be commensurate with skills and experience of successful candidate.
To apply for the QC Team Leader in GMP role:
Cover notes supporting your application are welcomed. On this occasion LiCa Scientific is acting as an employment agency.
Please email firstname.lastname@example.org with your most up to date CV and a cover letter.
Should you be keen to have an informal conversation ahead of application please email email@example.com and we’ll be happy to set this up.