Qualified Person
MicroPharm is a specialty pharma company which develops and manufactures life-saving medicines for the treatment of snakebite envenomation and poisonings. These products are “Specials” or licensed products.
Job Summary
We are looking for a permanent full time Qualified Person (QP) to join our team, reporting to the Chief Executive Officer. You will participate in all aspects of the management of the Quality Management System with the company’s site licenses (MIA, MIA(IMP), MS and WDA) in use at our sites in Newcastle Emlyn and Cilgerran in Mid-West Wales. The role will also involve certification of parenteral sterile (aseptic) drug product batches.
Key Responsibilities
- Completes the duties of a Qualified Person on site.
- Continuous improvement of the QMS ensuring inspection readiness.
- Support of external and internal Auditing, including regulatory inspections.
- Qualified Person certification of batches.
- Management of the Quality System.
- Management Review preparation.
- Management of licenses.
- Regulatory support.
- Tech Transfer and Clinical Trials.
- Quality Agreements.
- Function as a change agent, reviewing and improving established processes.
- RPI.
Qualifications, knowledge, skills, and experience required
- Eligible UK Qualified Person with relevant experience within the pharmaceutical industry.
- Detailed knowledge of current GMP requirements.
- Demonstrate coaching and mentoring skills.
- Commercially astute and customer focused.
- Excellent understanding of the pharmaceutical manufacturing sector in the UK.
- Excellent project management skills and demonstrates being a completer-finisher.
- Leadership experience with a strength of character to guide cross functional teams.
- Can demonstrate analytical and problem – solving abilities.
- Has a hands-on-approach with an enthusiastic can-do approach.
- Capable and confident communicator (both verbal and written) at all levels.
- Well organised with a logical and methodical approach to work.
- Excellent technical and scientific knowledge.
- Good Distribution Practice keeping abreast of current legislation, implementation and training of GDP within the company.
Please apply asap. If you have any questions or would like an initial conversation with our Human Resources Manager, Shona Evans, please contact her via email shona.evans@micropharm.co.uk
Applicants must have the right to work in the UK.
Successful candidates will be required to complete a basic disclosure check.