Responsible Person

Job Description

The Quality Assurance department are key to making sure the products made and distributed are of the highest standard and that all our departments are working in compliance with Good Manufacturing Practices. As 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 - FridayCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.