RP - Pharma
Posted 5 days ago by Skills Alliance
Negotiable
Undetermined
Undetermined
United Kingdom
Summary: The role of Responsible Person (RP) in pharmaceutical distribution involves ensuring compliance with Good Distribution Practice (GDP) and regulatory standards while maintaining quality across the supply chain. This part-time position requires oversight of the Quality Management System and active participation in audits and inspections. The RP will also manage quality incidents and advise senior management on compliance matters. The role demands a strong focus on quality and the ability to work independently.
Key Responsibilities:
- Act as the named Responsible Person in accordance with GDP guidelines and regulatory requirements
- Ensure all distribution activities comply with GDP and relevant regulatory standards (e.g. MHRA requirements)
- Oversee and maintain the Quality Management System (QMS), ensuring continuous improvement
- Review and approve SOPs, deviations, CAPAs, change controls, and risk assessments
- Ensure appropriate training, documentation, and record-keeping practices are maintained
- Support internal and external audits, including regulatory inspections
- Manage and investigate quality incidents, complaints, and non-conformances
- Ensure appropriate qualification and monitoring of suppliers and customers
- Provide quality oversight of storage, transportation, and distribution activities
- Advise senior management on quality and compliance matters
Key Skills:
- Eligible to act as a Responsible Person under applicable regulations (e.g. MHRA)
- Proven experience in pharmaceutical distribution and GDP compliance
- Strong knowledge of Quality Management Systems and regulatory frameworks (must be willing to use a paper system)
- Experience with audits and regulatory inspections
- Excellent attention to detail with a strong quality and compliance mindset
- Ability to work independently in a part-time capacity while maintaining oversight
- Strong communication and stakeholder management skills
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Role Overview We are seeking a qualified and experienced Responsible Person (RP) to support our pharmaceutical distribution operations on a part-time basis (16 hours per week). This role has a strong quality focus, ensuring full compliance with GDP (Good Distribution Practice) and regulatory requirements while maintaining the highest standards across our supply chain.
Key Responsibilities
- Act as the named Responsible Person in accordance with GDP guidelines and regulatory requirements
- Ensure all distribution activities comply with GDP and relevant regulatory standards (e.g. MHRA requirements)
- Oversee and maintain the Quality Management System (QMS), ensuring continuous improvement
- Review and approve SOPs, deviations, CAPAs, change controls, and risk assessments
- Ensure appropriate training, documentation, and record-keeping practices are maintained
- Support internal and external audits, including regulatory inspections
- Manage and investigate quality incidents, complaints, and non-conformances
- Ensure appropriate qualification and monitoring of suppliers and customers
- Provide quality oversight of storage, transportation, and distribution activities
- Advise senior management on quality and compliance matters
Key Requirements
- Eligible to act as a Responsible Person under applicable regulations (e.g. MHRA)
- Proven experience in pharmaceutical distribution and GDP compliance
- Strong knowledge of Quality Management Systems and regulatory frameworks ( must be willing to use a paper system )
- Experience with audits and regulatory inspections
- Excellent attention to detail with a strong quality and compliance mindset
- Ability to work independently in a part-time capacity while maintaining oversight
- Strong communication and stakeholder management skills
Desirable
- Experience working in a part-time or consultancy RP role
- Background in both wholesale distribution and quality assurance
Working Pattern Approximately 16 hours per week (flexible working pattern to be agreed) Some on-site presence may be required depending on business needs