Quality Compliance Manager / Responsible Person

West London
£0 per annum
13 Apr 2017
11 May 2017
William Blohm
Contract Type
Full Time
Our client is a privately owned pharmaceutical company which manufactures and distributes pharmaceutical and healthcare products to the UK market. They offer a wide range of products and services which includes specials, generic drugs, branded medicines, parallel trade and over-the-counter (OTC) medicines. Having undergone two acquisitions since 2010, and are looking to continue to strengthen and growing rapidly.

·Responsible for ensuring the licence provisions are observed and met
·To carry out the duties of the Responsible Person named on the Wholesale Dealer's Authorisation
·Responsible for ensuring that operations do not compromise patient safety and the quality of supplied medicines
·Responsible for ensuring that a compliant quality system is established and maintained
·Responsible for ensuring GMP and GDP compliance and best practice within all regulated activities
·Responsible for ensuring audits of the quality system are performed and to carry out independent audits
·Responsible for ensuring that adequate records are maintained
·Responsible for ensuring that adequate resource and capabilities exist within the quality assurance team and that all personnel are trained and developed in line with the requirements of their role.
·Responsible for the leadership of the quality assurance team and line management of staff, ensuring a high level of team motivation and morale
·Responsible for ensuring full and prompt cooperation with product licence holders is given in the event of recalls.
·To identify risks and to take necessary preventative measures pro-actively
Hosting and reporting of Regulatory inspections, Client Audits and supplier audits
Liaise with regulatory authorities (MHRA, Home Office) on Licence applications, drug returns and product recalls.

You will have previous experience of the storage and distribution of pharmaceutical products and current GDP standards and procedures. (Desirable)

·Pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy
·Degree in Quality Management life science or related field (desirable)
·Excellent communication skills: verbal and written
·Proven leadership capabilities in a senior quality role
·Ability to communicate effectively at all levels of the business
·Extensive knowledge of GMP and GDP and MHRA Guidance Note 14
·Practical experience in Supply Chain, Production and Quality Assurance
·Experience of hosting MHRA inspections, client audits and self-inspections
·Fully IT literate: Microsoft Outlook, Word, Excel, SAGE (desirable)
·Highly self-motivated with strong inter-personal skills
·Effective planning, organisational and administrative skills
Ability to work with cross-functional teams on new process projects, incident investigation, identification of root causes and process improvements

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