About the Role
Propharma-UK Ltd is establishing a new MHRA Manufacturer's Specials (MS) operation focused initially on non-sterile oral solid dosage forms, repackaging, relabelling and associated GMP activities.
We are seeking an experienced Quality Controller (QC) with direct experience in MHRA Manufacturer's Specials (MS) operations to play a key role in developing and implementing the Pharmaceutical Quality System (PQS), supporting the MHRA application process, and acting as the named Quality Controller on the licence where appropriate.
This is an exciting opportunity to build a new pharmaceutical manufacturing operation from the ground up.
Essential Requirements
Applicants must have demonstrable experience in one or more of the following:
- Direct experience working within an MHRA Manufacturer's Specials (MS) licensed facility.
- Experience supporting or leading an MHRA MS licence application.
- Experience acting as a named Quality Controller (QC), Production Manager, Responsible Person (RP), Responsible Person for Import (RPi), Qualified Person (QP), or equivalent regulated role.
- Strong knowledge of EU GMP, MHRA requirements, Pharmaceutical Quality Systems (PQS) and Quality Risk Management.
- Experience with MHRA inspections and inspection readiness.
Key Responsibilities
- Develop, implement and maintain the Pharmaceutical Quality System (PQS).
- Support the design and implementation of the MHRA Manufacturer's Specials operation.
- Develop and review GMP documentation including:
- Quality Manual
- Site Master File (SMF)
- Validation Master Plan (VMP)
- SOPs
- Batch Manufacturing Records (BMRs)
- Packaging Records
- Label Reconciliation Procedures
- Validation Protocols
- Lead deviation, CAPA, change control and risk management activities.
- Develop supplier qualification and technical agreement systems.
- Support equipment qualification and validation (DQ/IQ/OQ/PQ where applicable).
- Support MHRA application preparation and inspection readiness.
- Work closely with the Responsible Person, Compliance Manager and senior management team.
Desirable Experience
- Non-sterile oral solid dosage manufacturing.
- Repackaging and over-labelling operations.
- Validation and qualification activities.
- Computer System Validation (CSV).
- Importation of unlicensed medicines.
- Controlled Drugs (Home Office licensing).
- Warehouse GDP/GMP interface.
We Are Looking For Someone Who
- Has previously built or significantly developed an MHRA-compliant quality system.
- Can provide practical guidance rather than purely theoretical advice.
- Is commercially aware and able to support the development of a scalable pharmaceutical operation.
- Enjoys working in a growing entrepreneurial business.
- Can mentor and develop the internal quality team.
To Apply
Please submit your CV together with a brief summary covering:
- Your experience with MHRA Manufacturer's Specials (MS) licences.
- Your role in previous licence applications or licensed facilities.
- Experience as a named Quality Controller or equivalent.
- Experience developing PQS, SOPs, Validation Master Plans and Site Master Files.
- Your availability and preferred working arrangement (full-time, part-time or consultancy).
Please note: Preference will be given to candidates with direct MHRA Manufacturer's Specials (MS) experience and experience of taking a facility from concept through to MHRA approval.
Pay: £24,420.00-£40,419.12 per year
Benefits:
Work Location: In person
