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Qualified Person

Bannockburn, Stirlingshire
£75,000 to £85,000
Job Type
7 Sep 2022
Qualified Person My client a leading pharmaceutical wholesaler of both medical and pharma products is recruiting for a QP on a permanent basis based at the HQ in the central belt of Scotland site. The role is to assist in the process of maintaining compliance to Product Licences / Marketing authorisations and batch certification accordingly. In this role you will report to the Head of quality Key Responsibilities Responsibility for batch release as per EU/UK guidelines by ensuring the requirements have been met The batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant); Manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP); The principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation); Any deviations or planned changes have been duly approved. Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority. All necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff; All audits have been carried out as required by the QA system; Conduct Routine Quality Audits of the facility to ensure compliance with current EU/UK GMP, be proactive in resolving issues Set up and maintain the Internal Audit schedule and ensure its completion Conduct External audits, compile External Audit reports and manage associated Management and assistance with the site change control Provide technical support for New Product Introductions and existing Products, ensuring compliance with the registered dossier Provision / Updating of existing Quality Manual Procedures in order to ensure compliance with EU/UK GMP Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment Review and approve process and cleaning validation protocols and reports Key Requirements As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated - Directives 2001/20/EC and Article 51 of Directive 2001/83/EC. Minimum 2 years' experience in a similar role Pharmacy degree/Pharmacist Experience of implementing and maturing a quality management system Proven experience in change and project management Ability to develop and lead continuous improvement initiatives Experience of direct line management Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication Ability to lead a team and to build relationships and collaborate, Practical, action-orientated approach to managing priorities About us: Templarfox if a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency
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  • Job Reference: 706346579-2
  • Date Posted: 7 September 2022
  • Recruiter: TemplarFox Consultancy
    TemplarFox Consultancy
  • Location: Bannockburn, Stirlingshire
  • Salary: £75,000 to £85,000
  • Sector: Healthcare & Medical
  • Job Type: Permanent