Responsible Person

Job Description

Key Responsibilities

• To Ensure that the quality management system related to Good Distribution Practice is implemented and maintained as per the EU guidance on GDP (2013/C 343/01) and Human Medicines Regulation 2021.
• To Ensure the management of authorised activities and quality records are maintained accurately.
• To co-ordinate with manufacturers and promptly performing any recall operations.
• To Ensure customer complaints are dealt effectively.
• To Ensure all suppliers and customers are approved as per the procedures.
• To approve any subcontracted activities which are relevant to GDP.
• To Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• To Ensure appropriate records are maintained of any delegated duties
• To approve final disposition of returned, rejected, recalled or falsified products are dealt with effectively.
• To approve any returns to saleable stock.
• To ensure any additional requirements imposed on controlled drugs and unlicensed medicines maintained as per the regulations and procedures.
• To Ensure effective training of the Trainee Responsible Person.

Responsible Person duties:

• Responsible for maintaining the WDA License and ensure that variations are made to the license as required.
• Responsible for QA oversight of all GDP activities in all markets in accordance with local requirements; ensure product procurement, storage and distributions are managed in accordance with GDP requirements.
• Must have access to pharmaceutical knowledge and advice when required and must have personal knowledge of all the relevant GDP guidelines.
• Must have knowledge of the manufacturing, wholesale distribution and storage of unlicensed medicine in accordance to MHRA Guidance note 14.
• Ensure the conditions of WDA are met on which they are nominated

• Assess cold chain and ambient product shipments and provide corresponding quality decision on product quality and patient safety.
• Provide guidance and monitor quality issues related to cold chain, ambient products and GDP to resolution within the company and with external parties.
• Raise and review documentation including change controls, deviations, CAPAs, validation documentation, SOPs and specifications relating to distribution activities. Provide training if required.
• You will be responsible for maintain and conducting self-inspection as per schedule and audits of external suppliers.
• You will manage the follow up and close off complaint and deviations and support root cause analysis.
• Maintain, review and updating of Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
• Ensure Quality Technical Agreements are in place for all outsourced activities and with all sub-contactors.
• Provide Quality support and oversight for Distribution Operation review meetings with Distribution contractors.
• Contribute to defining standard GDP quality KPIs for all companies and to review quality indicators with recommendation for actions for improvement in relation to GDP contractors.
• Prepare for inspections from regulatory bodies such as the MHRA and the Home Office and provide support for regulatory submissions. Coordinate and support on-site audits conducted by external providers
• Ensure that the operations do not compromise the quality of medicines and requirements of WDA by ensuring that appropriate systems are in place to monitor the procurement, storage and distribution of the pharmaceutical products through the supply chainunder the control of the company.
• support third party warehouse activities from a quality perspective.
• Ensuring the appropriate CAPAs identified through any of the bove processes are implemented with appropriate timescales.
• Ensure effective temperature control of medicines.

Qualifications and Experience

• Degree level education in Pharmacy, Chemistry, Microbiology or Engineering
• Three years practical experience in handling, storage and distribution of medicinal products and transactions in or selling or procuring medicinal products.
• One years managerial experience in controlling and directing the wholesale distribution of medicinal products.
• Experience in implementation of a Quality Management System

Keyskills :
GDPQuality AssuranceQuality ManagementWholesaleCAPAs