Process Validation Specialist

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Process Validation Specialist - Central London Opportunity: This is a brand new opportunity that has been created due to expansion. My client a leading pharmaceutical company is looking to recruit a Process Validation Specialist where you will review process and analytical method validation status and reports against current standards and guidelines, identifying any gaps and working with the relevant departments to develop remediation plans. You will perform detailed validation gap analysis of process and analytical method validations (both chemical and biological) across a range of products per relevant SOP’s. Duties and responsibilities include: Maintaining and leading activities for the planning and implementation of any analytical and / or process validation master plans for all Marketing Authorisation’s (MA’s) held by the company. Reviewing and approving validation protocols and reports for upcoming products. Identifying gaps / discrepancies in the existing validation and proposing and leading appropriate remediation activities. Maintaining inventory for all existing process and analytical validation protocols and reports and ensuring SOP’s are followed throughout the process. Supporting the QP’ with batch release for reviewing key validation documents. This is a 12 months contract role based in the Central London area with a great salary paying between £30,000 - £35,000 per annum negotiable for the right candidate and fantastic benefits such as healthcare, pension, holidays…. Skills: To apply for the role of Process Validation Specialist you will have the following: Life Science degree with experience of carrying out the above duties ideally within the pharmaceutical or related scientific industry. Expertise in Analytical Method validation, Chemical Process validation and or Microbiological/Sterile process validation. Good working knowledge and understanding of relevant guidelines for validation including ICHQ2 guidelines and Annex 15 of the EU GMP guide. How to Apply: To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information. For a list of our current vacancies, please visit www.qualitystart.co.uk If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role. Quality Start are acting as a specialist recruitment consultancy for this role.

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