Responsible Person

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.

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