Gdp Responsible Person

1 month ago


Dartford, United Kingdom Radar Recruitment Full time

We are supporting a well-established and leading business within the healthcare sector, with hiring for an experienced Responsible Person to join their team during a period of growth within this organisation.

This Responsible Person hire is a part of a long-list of critical investments the business have made. You will be a key member of the compliance team, and have a real tangible as well as strategic input within a growing business. You will be accountablefor driving the culture of quality and compliance to the next level as the business continues to expand.

**The key responsibilities for the Responsible Person will involve**:

- 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.
- An experienced Responsible Person / GDP Quality Manager with a strong quality background currently working within industry.
- A degree in a relevant Scientific discipline would be advantageous as would a number of years working within an established quality team in a pharmaceutical organisation.
- Proven experience working as an auditor and development, implementation and maintenance of quality systems is essential.

**Keywords**: Responsible Person, Head of Quality, Quality Manager, RP, GDP, WDA (H)


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