Quality Manager and Responsible Person

As Site Quality Manager and Responsible Person you will be responsible for managing the Compliance and H&S department and ensuring the overall GDP compliance of the site.You will have a key responsibility in maintaining and developing all aspects of compliance management and Health & Safety profile of the site. Carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate compliance with EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) Human Medicines Regulations 2012 (C17) and all relevant legislations (COMAH EU Medical Devices Directive 93 / 42 / EEC etc.)Working hours: Monday to Friday 40 hour week.Key Duties of a Quality Manager: Named as the primary Responsible Person on the WDA(H) and Controlled Drug licence for site.Maintain and continually improve the companys Quality Management System in compliance with current GDP guidelines applicable certifications and group policies and procedures.Responsible for the generation revision approval of procedures and other GDP documentsResponsible for creation of annual self-inspection schedule performance of RP audits and management of self-inspections.Ensure that any subcontracted activities which may impact on GDP are approvedAct as the lead contact for MHRA client and corporate auditsResponsible for creation and review of Technical AgreementsCAPA and deviation management. Responsible for management of the investigation and resolution of operational discrepancies and customer complaints having final approval of outcome.Review and approve validation protocols and ensure that all systems are validatedDecide on the final disposition of returned rejected or falsified productsCoordinate and promptly perform any product recall operationsManagement of risk assessment programme and ensure that the mitigation strategies are defined and implementedResponsible for change management. Ensure that change control process in place for documentation processes and systemsOversee sampling and quality assurance release of productsEnsure that initial and continuous training programmes are implemented and maintainedReview and sign off temperature records and handle all temperature excursions. Ensure timely notification to the relevant party for all relevant product temperature excursionsHost Quality Management Review meetings collate monthly Quality stats and produce compliance reports.Manage team of 3 (Compliance and H&S Manager and 2 Quality Coordinators)Qualifications : You will ideally have a professional background and previous experience as an RP in the medical/pharmaceutical industry with key accountabilities to self-manage all requirements of an RPHold Cogent Gold Standard Training Certification for Responsible PersonsQuality Manager experienceKnowledge and experience of applying GDP guidelines and H&SExperience in examining and reengineering procedures and developing and implementing new strategies and proceduresEffective time managementStrong attention to detailStrong interpersonal and communication skillsConfidence and assertivenessExcellent IT skills (including Microsoft Office packages)Dynamic and self-motivated keen to achieve excellence within the businessAdditional Information : As part of our drive to make Great Bear a great place to work. We are proud to be an inclusive and diverse organisation where we are committed to employee development and recognising success for hard working performers.Our dedicated learning and development programmes are open to every employee to give you the opportunity to shape your own future within logistics and continue to work in an environment where team culture thrives.Our People are the driving force behind our success which is why we offer a wide range of benefits which include:Annual Leave Competitive holiday entitlement of 25 days plus the bank holidays.Pension scheme we want colleagues to enjoy a comfortable retirements so we offer a great contribution of 5% employee and 8% employer.Life Assurance -  x 4 your annual salary.Wellness Via our Employee Assistance Programme we offer immediate access to a confidential telephone counselling and legal information service that operates 24 hours a days 365 days a year.Eye Care Vouchers We can provide you with substantial savings with free eye tests and discounts on prescription glasses.Reward & Recognition We recognise that employees have gone the extra mile via Employee of the month and year special recognition and long service awards.Everyday discounts - via our benefit platform you will have access to over 50 retailer discounts for everyday savingsIf you meet the requirements for the above role and are looking for your next career opportunity please apply now and become a part of our #WinningTeamRemote Work : NoEmployment Type : Full-time Key Skills Accounts Management,Facilities Management,Law Enforcement,Administration Support,ERP,Development Experience: years Vacancy: 1