About Us
Propharma-UK Ltd is an MHRA-licensed pharmaceutical wholesaler (WDA(H)) operating from a GDP-compliant facility in the UK.
We are seeking an experienced MHRA Specials Manufacturing Consultant to support the development and application of a Manufacturer's Specials (MS) Licence for a non-sterile pharmaceutical operation.
This is a practical implementation role focused on obtaining an MHRA MS licence and establishing a compliant GMP operation within our existing premises.
Proposed Scope of Operation
The proposed MS operation will initially focus on:
- Repackaging of medicines
- Breaking bulk of medicines
- Relabelling and over-labelling
- Non-sterile oral solid dosage forms (tablets and capsules)
- Supply of unlicensed medicines (specials)
- Future importation of non-sterile unlicensed medicines
- Potential future controlled drug activities
The operation will utilise existing premises currently operating under an MHRA WDA(H) licence.
Key Responsibilities
- Review existing premises and advise on suitability for MS licensing
- Define MHRA licensing strategy and application scope
- Conduct GMP gap analysis
- Develop implementation roadmap
- Advise on premises layout and workflow design
- Support MHRA application preparation and submission
- Develop or adapt GMP quality systems
- Advise on validation requirements
- Assist with equipment selection and qualification requirements
- Support inspection readiness activities
- Provide practical guidance through to licence approval
Essential Experience
Applicants must demonstrate:
- Previous successful involvement in obtaining MHRA Manufacturer's Specials (MS) Licences
- Strong knowledge of UK GMP requirements
- Experience within non-sterile pharmaceutical manufacturing environments
- Experience with repackaging and relabelling operations
- Experience supporting MHRA inspections
- Practical GMP implementation experience
- Experience developing pharmaceutical quality systems
Highly Desirable
- Former Head of Quality, Technical Manager or Senior Quality professional within a Specials Manufacturing environment
- Experience with imported unlicensed medicines
- Experience with controlled drug handling and licensing requirements
- Experience converting GDP operations into GMP-compliant manufacturing operations
- Experience supporting MHRA licence variations and new licence applications
Documentation & Templates
Applicants should ideally possess existing GMP documentation and implementation templates that can be adapted for our operation, including:
- SOP templates
- Quality Manual templates
- Batch Manufacturing Records
- Packaging Records
- Label Reconciliation Forms
- Validation Protocols
- Training Documentation
- Deviation, CAPA and Change Control templates
- Internal Audit templates
Please indicate what documentation packages you currently possess.
Compensation Structure
We are open to:
- Fixed project fee proposals
- Daily rate consultancy arrangements
- Retained consultant arrangements
- Ongoing part-time technical support following licence approval
Please specify:
- Your preferred engagement model
- Daily rate
- Project fee (if applicable)
- Availability
Mandatory Application Questions
Please answer the following:
- How many MHRA Manufacturer's Specials Licence projects have you personally worked on?
- Have you successfully obtained an MHRA Manufacturer's Specials Licence for a non-sterile operation? If yes, please describe your role.
- Have you worked on repackaging, relabelling or breaking bulk operations?
- Do you possess GMP documentation templates and SOP packs that can be adapted for implementation?
- Have you converted an existing GDP wholesale operation into a GMP/MS operation?
- What is your daily rate and availability?
- Please provide a brief summary of the most relevant MS project you have worked on.
We are seeking a practical, hands-on consultant who has successfully delivered MHRA MS licence projects and can guide the business from planning through to licence approval.
Pay: £200.00-£300.00 per day
Benefits:
Work Location: Hybrid remote in London SW19 2TJ
