QA & Validation Specialist- Pharma - Cambridge/Newmarket/Bury St Edmunds - £35,000 - £40,000My client is a leading pharmaceutical company globally and they are looking for experienced Quality & Validation professionals from a pharmaceutical or medical device background to join their organisation on a permanent basis. They are currently looking for a technical specialist and an officer to join their department and the company offers excellent scope for development. If you are interested in hearing more about this opportunity apply now via the website or call Joseph Tiffin on 0161 868 2214 for more information.Responsibilities;* Maintain a local change control process to ensure all changes are fully documented* Ensuring all changes are assessed for risk and impact prior to implementation* Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame* Ensuring all equipment used for the manufacture and storage of product is validated before use* Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.* GMP and Facilities and Equipment Control* Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.* Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete* Investigation of out of limits results using exception and CAPA processes* Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards* Quality System Measurement and Review* Corrective and Preventative Action* CAPA owner and leader* Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time framesRequirements;* Degree qualified in a relevant Engineering or scientific discipline* Experienced working in the pharmaceutical industry ideally in a sterile or aseptic environment* Experienced in reviewing and executing CAPA's* Experience ensuring equipment is fully compliant with Quality and validation regulatory requirementsIf you believe you meet the requirements and you are interested in hearing more about the role apply now via the website or call Joseph Tiffin on 0161 868 2214.
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