Quality Manager – QP
Brighton & Hove, East Sussex
Competitive salary and benefits package
We are looking for a permanent, full-time Qualified Person.
Company Description
About Custom
Custom Pharma Services is an established contract development and manufacturing organisation with a broad portfolio of commercial and development products. We have a proven track record of designing and developing new oral solid dose formulations, supporting our clients from formulation development to clinical then to commercial scale manufacturing and packaging.
Custom is a great place to work where teamwork and support is encouraged, where every individual is valued and supported to achieve their full potential because if you can, then Custom Can!
This is an exciting time to join us as we embark on a major project to complete the build of our new manufacturing facility in Brighton & Hove.
Key responsibilities are:
- QP certification of IMPs and marketed products
- Continuous improvement of the QMS ensuring inspection readiness
- Support, review and approval of investigations, deviations, change proposals and product quality complaints
- Drive improvement initiatives based on review of quality system metrics
- Act as a change agent, reviewing and improving established processes
- Maintain effective communication with internal and external clients
- Support of regulatory and client audits
- Coaching and developing the team in line with the Company’s policy of being an ‘Investor in People’
About You
Qualifications, knowledge, skills & experience required:
- Eligible to act as a QP in the UK (Commercial and IMP)
- Demonstrated experience as a releasing QP (ideally oral solid dosage)
- Excellent scientific and technical knowledge
- Excellent knowledge of the principles and guidelines for GMP and GDP as per: UK Orange Guide, Eudralex Volume 4, US CFR’s and other relevant regulations.
- Well organised with a logical and methodical approach to work.
- Excellent written and verbal communication skills.
- Leadership experience with strength of character to guide cross-functional teams of professionals.
Benefits package includes:
Hybrid working on completion of probation period; Individual bonus payment based on successful performance; Pension; Life Assurance; Health Plan and Subsidised Gym Membership
Relocation support offered to candidates not based within commutable distance
If you have any questions or would like an initial conversation with our Recruitment Manager, Jane Austen, please contact her via email: Jane.Austen@custompharma.co.uk
Applicants must have the right to work in the UK.
Successful candidates will be required to complete a basic disclosure check.
www.custompharma.co.uk