Experience

Allergy Therapeutics

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Validation Project Leader

  • Mar 2022 - Present

• Senior Validation Engineer

  • Jun 2009 - Present

  Responsible for the generation of initial versions of site Master Validation Controlling documents, PV & CV Risk Assessments as precursor to preparation and execution of: Validation life cycle documentation for projects related prospective and retrospective processes and equipment (including VMP, Impact Assessments, Gap Analysis Report, URS, FS, IQ, OQ, PQ and VSR).- Planning, preparation and performance of cleaning validation studies for process equipment interfaces.- Fulfil the role of site Validation ‘’Sterilisation Expert’’, generated novel site sterilisation strategy and autoclave load validation review report; to ensure both user requirements and sterilisation compliance are meet. These documents provide a metric against which continued autoclave load validation can be performed. Loads are risk assessed to determine extremes of process and thus determining the requitred requalification effort. Show less



Allergy Therapeutics plc

• Validation Technician

  • Jan 2006 - May 2009

  Initial member of Validation Team in 2006 to qualify critical processes, direct impact equipment and utilities and standard analytical methods within the pharmaceutical company in accordance with cGMP and industry standards to comply with required regulations: Prepare all documentation in accordance with company procedures and cGMP. Assist in writing, and approval of URS's and SOP's, where applicable. Prepare and review Technical Specifications (where applicable). Execute IQ/OQ/IOQ/PQ protocols. Prepare, review and approval of relevant IQ/OQ/PQ protocols and reports. Ensure compliance to company internal validation procedures. Provide personnel as necessary to set up and run the equipment and provide operator training where applicable. Involved in MHRA audit Show less

• QC Microbiologist

  • Apr 2004 - Dec 2005

  QC Microbiologist, undertaking routine analytical procedures to current GLP & GMP standards, methods includes bioburden & endotoxin analysis to assure the quality of vaccine product at various stages, including raw materials. I performed validation work prior to commencing full time role, in order to justify the effectiveness for use of certain laboratory and production systems, e.g. BIs, Autoclaves, container integrity, temperature controlled units, VHP and sterile grade filters to meet with BS ISO standards, EP & to attain compliance with USP - FDA regulations. Trained as investigator of Non-Conformances of Quality Systems. Show less



Allergy Therapeutics

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Validation

  • 2004 - 2009

  Devised Business Risk Based Approach to Process, Cleaning and Sterilisation Validation Devised Business Risk Based Approach to Process, Cleaning and Sterilisation Validation



Robens, Centre for public and Environmental Health

• Microbiologist

  • May 2002 - Apr 2004

  Concerned with water quality monitoring by utilising the appropriate organism enumeration/ detection methodology, incorporating the necessary confirmation and identification processes such as diagnostic labelling of cultured suspect Legionella species' isolates with a spectrum of fluorescent labelled serogroup discriminating antibodies prior to performing microscopic analysis. Further employment activities undertaken comprised the preparation and quality control of media; calibration of balances, pipettes and thermometers. Routine maintenance and checks on the incubators, water baths. I periodically undertook the writing of reports and laboratory documentation in accordance with the directions of the head of microbiology. I also assisted with customary enquiries from clients about the status of their samples and the promotion of services offered by the laboratory. Therefore I contributed to the operation and development of the Microbiology laboratory, which achieved UKAS accreditation whilst I was employed at the centre, which is also Show less



South East Water UK

• United Kingdom
• Water Supply and Irrigation Systems
• 300 - 400 Employee

• Cryptosporidium Analyst

  • Mar 2002 - Apr 2002

  Analysis of specific point water samples (ground water/ reservoir/ treated) for presence or absence of Cryptosporidium protozoan parasite. Analysis of specific point water samples (ground water/ reservoir/ treated) for presence or absence of Cryptosporidium protozoan parasite.



Leatherhead Food RA Ltd

• Microbiologist

  • Dec 2001 - Mar 2002

  Assistant Microbiologist, I performed routine bacteriological quality analysis of food products utilising a range of standard microbiological enumeration/ isolation methods. Assistant Microbiologist, I performed routine bacteriological quality analysis of food products utilising a range of standard microbiological enumeration/ isolation methods.