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Job Post Details

MHRA Specials Manufacturing Consultant (Non-Sterile Operations) - job post

Propharma-UK
London SW19 2TJ•Hybrid work
£200 - £300 a day - Temp to perm
Responded to 75% or more applications in the past 30 days, typically within 3 days.

Job details

Pay

  • £200 - £300 a day

Job type

  • Temp to perm

Location

London SW19 2TJ•Hybrid work

Benefits

Pulled from the full job description

  • On-site parking

Full job description

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:

  • On-site parking

Work Location: Hybrid remote in London SW19 2TJ

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