CV-Library
Responsible Person
We are recruiting on behalf of our client for a Responsible Person (RP)
* The role – Responsible Person (Healthcare)
* Salary is negotiable
* Location – Our clients Offices are in London (They are open to flexible working)
* Hours- 32 hours or 40 hours a week
* Holidays – 33 days paid (Including Bank Holidays
* Health & Dental Insurance
Role Requirements
• To have knowledge of the activities to be carried out and have adequate
experience relating to those activities and procedures.
• Ensuring that the conditions under which the licence has been granted have
been, and are being complied with.
• Ensuring that the quality of medicinal products handled by the licence holder
is being maintained in accordance with the UK marketing authorisation.
• Appropriate knowledge of regulations and guidance in relation to the
wholesale of medicinal products for human use and maintenance of a
WDA(H).
• To fulfil responsibilities personally; may delegate duties but not responsibilities.
Regulations and related guidance
• Human Medicines Regulations 2012 (as amended)
• MHRA Rules & Guidance for Pharmaceutical Distributors (Green Guide)
• Advertising and Promotion of Medicines in the UK (Blue guide)
Relationships
Reports to Chief Operations Officer (COO) / Chief Executive Officer
(CEO)
Indirect relationships Subcontractors
Duties and responsibilities of Good Distribution Practice (GDP)
To ensure compliance with the guidelines on Good Distribution Practice
published by the European Commission ((2013/C 343/01) MHRA Rules &
Guidance for Pharmaceutical Distributors (Green Guide) and the
requirements of The Human Medicines Regulations, 2012, as amended.
Quality Management System
To implement and maintain a QMS, including change control, deviation and
CAPA procedures.
Quality Management Review
To attend and participate in the review meetings; provide an agenda for
each meeting; ensure the outcome of each meeting is documented by
producing minutes of the meeting.
Complaints
Ensure that complaints are handled effectively and appropriately, including
quality and service complaints, pharmacovigilance (AE/ADR reports) and
medical information enquiries.
Subcontracted activities
To assess the risk of, and approve or reject suppliers of services that impact on
GDP; to maintain valid agreements with subcontracted suppliers, audit
subcontracted suppliers at an appropriate frequency; record, investigate
and risk assess deviations.
Customer approval
Ensure that customers are approved before being supplied with medicinal
product and ensure that customers who fail to meet the approval criteria are
rejected.
Recall
To coordinate and promptly perform any recall operations, in conjunction
with the DMRC and / or the MAH; ensure that documentation regarding the
recall is maintained and make it available to the competent authorities or
MAH if requested; record the progress of the recall in a final report; conduct a
‘mock’ recall annually, unless a genuine recall has occurred.
Falsified medicines
To immediately inform the MAH, MHRA (DMRC) and the Directors about any
known or suspected falsified medicine.
Disposition of medicinal product
Deciding on the final disposition of returned, rejected, recalled or falsified
products – note that in practice, returns are not accepted.
Document control and record retention
To control version numbers where appropriate and other unique identifiers;
when documents such as SOPs or Technical Agreements are updated, to
archive the superseded version; keep a list of current SOPs and agreements.
Computerised systems
To ensure computerised systems follow GDP guidelines and data integrity
guidance.
Business continuity
Ensure business continuity plans are in place and to check them as part of the
self-inspection process
Inspections by competent authorities
Support the licence holder in inspections by competent authorities by
appropriate review and preparation, including responses to any findings.
Maintenance of the WDA(H)
Support the licence holder to prepare, submit and manage any changes to
the WDA(H).
Training
Implement and maintain continuous training programmes for company
employees.
Other
Ensuring that any additional requirements imposed on certain products by
national law are adhered to
£60000 – £70000/annum private healthcare