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Quality Control Analyst

4 months ago

Grangemouth, United Kingdom Piramal Pharma Solutions Full time
To execute defined and trained Quality Control department tests for the release of raw materials, in process products, bulk drug substance, final products and stability products according to defined procedures and protocols and according with best cGMP work practices, Quality standards and metrics

Responsibilities

Perform batch disposition and stability activities in a proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products andstability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 GoodnDocumentation Practices for Electronic Data.nPerform stability study programme activities, storage of in process, and final products samples and retention sample managementnSystem owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department.nOwnership and accountability of deviations, investigations and laboratory investigations and timely completion of these documentsnPreparation and update of SOPs, instructions and protocols and other Quality Control documentationnChecking and reviewing of data in compliance with Data Integrity requirementsnActively contribute to department and site audit readiness requirements including any continuous improvement initiatives.nCalibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibrationnMaintain Quality Control information systemsnMaintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC AnalystnAssist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner.nAttend internal and external scientific and technical meetings and conferences where appropriatenCarry out general maintenance and house keeping of equipment and laboratories

Essential Experience

Experience within a QC laboratory working to GMP within a recognised quality system.nAbility to organise work within a busy laboratory with experience of writing and working to SOP documentation.nKnowledge of GMP guidelines and regulatory bodies