Our client, a leading pharmaceutical business who work across a large portfolio of products, are looking to hire an experienced and well qualified Responsible Person (RP) to join the business to work as part of their management team.
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The Responsible Person will play a key role within the business, and be named on the company's WDA Licence, with the view of providing key guidance as well as strategic direction related to GDP across the business and to 3rd party suppliers. You will interface and have a close relationship with CMO's to ensure they are adhering to the GDP guidelines at all times.
The key responsibilities for the Responsible Person will involve the following:
* Responsible for maintaining the WDA License and ensure that variations are made to the license as required.
* Provide 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.
* Provide advice to senior management when required and must have personal knowledge of all the relevant GDP guidelines.
* Ensure the conditions of WDA are met on which they are nominated.
* 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 and to review quality indicators with recommendation for actions for improvement.
* Prepare for inspections from regulatory bodies (eg. MHRA and Home Office) and provide support for regulatory submissions.
* Coordinate and support on-site audits conducted by external providers
* Provide support to third party warehouse activities from a quality perspective.
* Ensuring the appropriate CAPAs identified and implemented with appropriate timescales.
The ideal candidate for the Responsible Person (RP) role will have the following background:
* Degree qualified and have extensive experience in a GDP environment, ideally as a Responsible Person (RP).
* Must have worked within the Pharmaceutical, or related sectors.
* You will have strong 3rd party management experience and have a thorough background in ensuring strong GDP processes are put in place across an expansive supply chain network.
* You will ideally have experience working with CMO's (Contract Manufacturing Organisations)
* You must also have previous experience in implementing/providing improvements to Quality Management System's to ensure compliance with GDP standards.
Keywords: Responsible Person, RP, GDP, WDA, WDA(H), QMS Manager, Good Distribution Practice
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