Experience

MicroPharm Limited

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Manager

  • Jun 2019 - Present



Scitech

• Validation Project Manager

  • Jun 2014 - Jun 2019



Scitech

• Validation Consultant

  • Jul 2016 - Dec 2016

  Supporting qualification of new Clean Room facility for Embolic Beads manufacture including EMS, UDAF, Purified Water Generation and Distribution System, Clean Compressed Air, Nitrogen Supply, Hydrogen Supply and Process Waste Handing System . The work comprised- Generation of Equipment Impact Assessments- Generation of Equipment Validation plans- Generation of DQs and Traceability Matrices- Generation and execution of IQ and OQ protocols and Validation Reports

• Validation Project Manager

  • Sep 2014 - Jul 2016

  GSK Montrose Responsible for all validation aspects related to the qualification of a new automated Biotech manufacturing facility and associated equipment (40 systems).− Management of internal Validation staff and external Validation contractors.− Writing and maintenance of the Project Commissioning and Qualification Plan.− Management and execution of the Design Qualification Process.− Management and execution of the Factory Acceptance Testing. − Generation and execution of facility, utilities and equipment IQ & OQ protocols using the GSK CQS system.

• Validation Consultant

  • Jun 2014 - Sep 2014

  Supporting the Validation Manager in the review, generation and execution of IQ, OQ and PQ protocols for equipment items related to the contract manufacture of Biotech products, including- IQ, OQ and Cleaning Validation of mobile vessels for fermentation area. - Quality Risk Assessments for Fermenters- Performance Qualification for Freezers and Cold Stores



Penn Pharmaceutical Services Ltd.

• Validation Team Leader

  • Jul 2011 - Jun 2014

  Validation Team Leader, Technology Transfer Group − Responsible for all validation aspects related to the introduction of a new high potency manufacturing facility and associated equipment. − Responsible for all validation aspects related to the introduction of a new solid dose manufacturing facility and associated equipment. − Management of internal Validation staff and external Validation contractors. − Generation of Validation Master Plans for new facilities, equipment and processes. − Maintenance of Site Validation Master Plan, Validation Policy and related SOPs. − Generation and execution of facility, utilities and equipment protocols and process validation protocols. − Validation of computerised systems including Electronic Document Management System upgrade, Environmental Monitoring System and Asset Management. − Generation of qualification and process validation reports. − Training of staff involved in relevant Validation subjects. − Validation representative in Client and regulatory audits. − Driving improvements in validation procedures to focus on critical aspects of equipment and processes during protocol execution in accordance with industry best practice and regulatory expectations. Validation Specialist, Technology Transfer Group − Key validation contact for new products and equipment and process improvement projects. − Generation and execution of process validation protocols for new product introductions for key clients. − Generation of process validation reports. − Training of staff involved in new product introductions. − Validation representative in Client and regulatory audits.



BTG plc

• United States
• Medical Device
• 200 - 300 Employee

• Validation Manager

  • Feb 2002 - Apr 2011

  − Overall responsibility for the validation of facilities, equipment, processes, assays and software at the MHRA and FDA regulated production facility in West Wales. This includes generation of plans, protocols and reports and scheduling of work with validation staff and other departments plus external contractors. − Advisory role on validation at other BTG sites. − Other key roles include leadership of the Purified Water Committee, representation of the Validation department during audits and regulatory inspections, continuous improvement of the validation systems to ensure timely documentation review and compliance with regulatory guidelines and update of the Site, Shipping, Cleaning and Process Validation Master Plans. A key member and contributor to the following major project teams as a core member or project leader: − Development and manufacture of clinical trial material for the treatment of severe sepsis in partnership with a global pharmaceutical company. Generation and execution of the process validation master plan, sampling plan and other supporting documentation. − Relocation of the manufacture of Bulk Immunogens to scale-up and simplify the process. − The introduction of a second contract filling and freeze drying contractor and subsequent transfer of core products to this facility. − Scale-up of the lead production process: an ovine derived polyclonal antibody for the treatment of rattlesnake bites. − Construction of a production facility expansion and subsequent integration with the existing facility. − Scale-up of the Purified Water and WFI systems. − The purchase, installation and qualification of a new centrifuge and autoclave. − Process validation of the lead development project: - a treatment for methotrexate toxicity. Worked with contract manufacturing companies to ensure successful validation of the manufacturing process from fermentation to filling and freeze-drying. Contributed the validation sections to the Common Technic



CeNes Drug Delivery Ltd

• Irvine

• Production Manager

  • Sep 1999 - Feb 2002

  Production Team Leader, then Production Manager − Scheduled product manufacture against orders from external Marketing partners or internal departments and assigned resources accordingly to successfully meet deadlines. − Planned and implemented GMP training for staff members and carried out annual appraisals. − Represented the Production department during regulatory inspections. − Worked with external consultants to improve process efficiency and managed the development of new manufacturing processes. − Responsible for the process validation of the lead hydrogel product in 2000. After successful validation of the process, ensured the launch stock was manufactured and supplied to Marketing partners in accordance with deadlines.