Responsible Person
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.
Role Objectives:
The Responsible Person (RP) is an integral role within the company to ensure that EU Good Distribution Practice, national regulations, and provisions listed on the Wholesalers Distribution Authorisation are met and complied with at the company. The objective is to assure quality, safety, and traceability throughout the supply chain in order to protect end-users from harm. This is done by ensuring that an effective Quality Management System is maintained with oversight from the RP.
The Ideal Candidate:
- Strategic
- Collaborative
- Proactive
- Adaptable
What You'll Do:
Ensure a quality management system is implemented and maintained, including the review and approval of GDP procedures, and remain continually contactable as the RP.
Ensure the principles of Quality Risk Management are applied to all RP duties and responsibilities, and that obligations to the Falsified Medicines Directive are met.
Participate in Quality Management Review Meetings, ensuring minutes are taken and actions are brought to closure in a timely manner.
Assess and approve GDP Change Controls, with oversight of Deviations and CAPAs (Action Items) as appropriate.
Focus on the management of authorised activities and the accuracy and quality of records.
Ensure initial and continuous training programmes are implemented and maintained, and keep up to date with legislative changes and ongoing training as identified.
Coordinate and promptly perform any recall operations for medicinal products, and ensure relevant customer complaints are dealt with effectively.
Ensure that suppliers and customers are approved.
Approve any subcontracted activities that may impact GDP, including contracts between the contract giver and acceptor specifying their respective responsibilities for wholesaling activities such as storage, distribution, and transportation of medicinal products.
Ensure self-inspections are performed at regular intervals following a prearranged programme, with necessary corrective measures put in place.
Decide on the final disposition of returned, rejected, recalled, or falsified products, approve any returns to saleable stock, and ensure any additional requirements imposed on certain products by national law are adhered to.
Delegate duties when absent and keep appropriate records of any delegation, and provide line management as needed, including setting clear objectives, supporting development, and managing performance.
- May take on the responsibility as the Deputy RP for the UK .
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- Significant experience and demonstrated industry knowledge (preference for GDP setting)
- Completion of the Responsible Person training program and/or refresher program
Extensive knowledge of GxP requirements, including but not limited to GMP, GDP, and GCP for EU/FDA/WHO, and appropriate regional research regulations and guidelines
Extensive knowledge of Good Distribution Practice national regulations and associated guidelines, with the ability to interpret legislation and assess requirements
Effective verbal and written communication skills, with strong interpersonal skills
Ability to use initiative, think critically, and make effective decisions
Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy
Strong organizational, planning, and administrative skills, with attention to detail and high self-motivation
Ability to work proficiently within the Microsoft Office Suite, including Word, Excel, and PowerPoint