Application consultant Work, Jobs in Whyteleafe, Sry (with Salaries)

MHRA Specials Manufacturing Consultant (Non-Sterile Operations)
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Quick apply
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MHRA Specials Manufacturing Consultant (Non-Sterile Operations)

Propharma-UK -
London

Quick apply

Job details

Temp to perm
£200 - £300 a day
5 days ago

Benefits

On-site parking

Qualifications

Business analysis
Analysis skills
Bachelor's degree
Microsoft Project

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

Quick apply

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