Leads, prioritises and provides an effective product release service which ensures that all products released for sale or further processing have a quality appropriate to their intended use – to comply with company GMP standards and product quality specificationsExcellence in Deviation Management – Deviations and CAPAsEnsure that periodic product reviews are performed for all productsDirects investigative work into products failing to meet requisite standards and recommend rejection or rework as appropriate. Develop and agree corrective actions arising from such incidentsQuality approval on commercial batch and fill/pack documentationDirects investigative work into regulatory issuesTechnically review and approve QA SOPsAuthorise non-QA standard SOPs on behalf of OQApproves procedures, complex protocol method statements utilised within relevant business areaEnsure that the Quality Manager and relevant production stream management are notified of any deviations from GMPProvide GMP Advice on an on-going basisParticipate and lead internal audits of relevant production and support areas and manage action follow-upsLead improvement projectsPromote Quality Improvement activitiesEnsure that technical terms of supply are in place for relevant productsEnsure that OQ staff are aware of relevant HSE regulations and initiatives, COSHH surveys and safe working practiceProvision of specialist advice on services – building managementManagement of agreed service levels on document/batch reviewsProvide OQ representation on projectsProvide OQ input to various aspects of engineering functions specific to the areaInvestigate and report customer complaintsPrepare OQ training material, and provide training if requiredReview engineering change controlsManage document archive activities

Lead the manufacturing scale-up of development batches, conduct technology transfer of new products in to commercial manufacturing facilities,Lead the manufacture of new products at pilot plant scale to supply product for use in pivotal stability and commercial trails.Write and/or review/authorise GMP-critical documentation, such as experimental reports, validation protocols, batch records, development and technology transfer reports.Plan and implement process development experiments at laboratory and/or pilot plant (1/10th) scale, using tools such as DoE and report the results.Specialising in process development and cleaning validation for Suncare productsDepartment COSHH and DSEAR assessor Departmental records championHead of cleaning development and validation for new formulationsDepartment audit leadCHRD Career & Development ChampionContinuous improvement including implementation of 5S and KanbanMember of the CARE commiteeMentoring and training new members of the team Design and implementation of structured training plansManufacture support and troubleshooting of existing productsWork continuously to improve existing manufacturing processes and proceduresTrained swabber for cleaning validationManagement of raw material requirements and schedulingStrong knowledge of raw material and physical propertiesStrong knowledge of COMET (inventory management system)SAP experienceScheduling of department project plansLarge understanding GMP and EHS standards.Accountable for Process Improvements, and resolution of Day to Day technical issuesOrganising, completing and reporting technical trials to support development and validation exercises.Deviation and CA/PA ManagementPhysical analysis of samples – microscopy, rheologyLead department and SITE user of CLS (Core Lab Systems).Implementation new pieces of production equipment into the plant.Advanced user of Microsoft Excel

DUTIESExperienced in writing and reviewing SOPs, Reports, Protocols and Risk AssessmentsImplementation, training and maintenance of QMSExcellence in Deviation Management – Deviations and CAPAsCoordinates department QMS tools for Change Controls, Deviations and CAPAsProvide leadership and support for Quality Investigations, Root Cause Analysis and CAPAManage Quality MetricsResponsible for review of batch manufacturing records.Responsible for release of products and raw materials/packagingAuditor for self-inspections and cross-auditsSupporting R&D team, including scheduling of work, training operators and personal developmentExperienced in the use of a range of software programs including Excel, Word, PowerPoint and QMS tools including TrackwiseQuality motivated, dedicated to maintaining high standards and accustomed to working to tight deadlines