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Form of workAs a Responsible Person your responsibilities will include, though will not be limited to:
- Ensuring that a quality management system is implemented and maintained.
- Managing of authorized activities and the accuracy and quality of records.
- Ensuring that initial and continuous GDP training programmes are implemented and maintained.
- Coordinating and promptly performing any recall operations for medicinal products.
- Ensuring that relevant customer complaints are dealt with effectively.
- Ensuring that supplied and customers are approved.
- Approving any subcontracted activities which may impact on GDP.
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
- Deciding on the final disposition of returned, rejected, recalled, or falsified products.
- Having full knowledge of the Licence Holder and the activities that it undertakes.
- Ensuring that the Licence Holder is complying with the conditions of the licence issued.
- Ensuring that the guidance on Good Distribution Practice (GDP) are complied with.
- Ensuring that products are being stored under the correct storage conditions.
- Regularly monitoring all named sites.
- Receiving reports when tasks are delegated to the Deputy Responsible Person.
- Being vigilant, to ensure that falsified medicinal products do not enter the supply chain.
- Keeping appropriate records of any delegated duties.
- Approving any returns to saleable stock.
- Ensuring that any additional requirements imposed on certain products by national law are adhered to.
- Understanding relevant legislation and its application including:
- Human Medicines Regulations 2012 (SI 2012/1916)
- Directive 2001/83/EC as amended
- Guidelines of 5 November 2013 on Good Distribution Practice of Medicinal Products of Human Use (2013/C 343/01)
- Having a working knowledge of the role and scope of the MHRA and EMA including:
- The inspective process
- Licensing
- Maintenance of the WDA(H)
- Assisting with product quality complaints when RP input is required.
To be successful in this role, you should be able to demonstrate:
- Previous experience as a Responsible Person
- Strong, up to date knowledge of Good Manufacturing Practices
- A supportive nature - and good team-playing mentality
- Being capable of working towards KPIs
- Excellent communication skills
- The ability to work at pace and in a high-pressured environment
Working hours for this role are 09.00 - 18.00, Monday - Friday
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
