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Job Location | Corsham |
Education | Not Mentioned |
Salary | 26,000 - 29,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
Validation LeadAbout usThe Qualasept Pharmaxo Holdings Limited (QPHL) Group operates within the pharmaceutical aseptic compounding, clinical homecare and laboratory services sectors.Qualasept Ltd t/a Bath ASU produces over 3,000 aseptically compounded injectable pharmaceutical products each day for hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need of pain relief. Through our scientificand technology capabilities, the team continuously develops new and innovative methods to improve our products and services.Pharmaxo Pharmacy Services Limited is a growing clinical homecare provider in an expanding market offering greater convenience to patients whilst delivering efficiencies to the NHS.Microgenetics Ltd is a bio-technology business, currently offering two products: SmartControl and SwiftDetect. It operates both in the pharmaceutical and agricultural markets, bringing innovative microbiological testing and monitoring services, methodologiesand technologies.Corsham Science Ltd uses cutting-edge science and technology to deliver healthcare services, medicines, and microbiological testing products.The QPHL Group now includes over 400 people with a leading-edge turnover greater than £260 million.We have invested in a new, multi-million pound manufacturing facility and offices in Corsham, WiltshireYour roleAs Validation Lead you will deliver a safe quality aseptic manufacturing service to meet cGMP requirements and the needs of the business. The role holder will be expected to provideadvice on all aspects of Validation to support the quality, efficacy andsafety of all products manufactured at Bath ASU.You will be involved in the complete life cycle for commissioning of facilities, equipment, utilities, and processes, with focus on end-to-end Validation.This includes following the entire Validation Life Cycle, from the generation, execution, and reviewof life cycle validations documentation, developing some Key Validation Deliverables, through to assessing and mitigating Risks, planning for Validation approach and Test Strategy, Analysis, Review & Approval of Requirements and Change Management.This position will support the Pharmaceutical Quality Management System through the creation of appropriate validation/qualification reports and presentations.You are responsible for leading the trending and review of validation data; for coordinating and producing investigation reports and assessing CAPA action items.The role will involve liaising with departments including QA / QC, Production, Warehouse, IT and Maintenance as well as visits to the aseptic processing facilities.Your duties & responsibilities