Ed Andrew work email
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Ed Andrew personal email
A Chartered Chemist with over thirty years experience in quality assurance and validation of API and parenteral manufacturing; covering fermentation, synthetic chemical, enzyme catalysed processes and Radiopharmaceuticals and facilities supplying markets worldwide, including the USA. I have participated in several FDA and MHRA audits involving discussions with inspectors. I have lead teams in laboratory, operational quality and compliance management roles and worked with products for clinical trials, small and large scale manufacture.
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Gmp Quality ManagerPerceptive Inc. Mar 2020 - PresentLondon, England, United Kingdom -
DirectorQualera Ltd Apr 2019 - Feb 2021 -
Interim Quality Manager (Contract To Oct 2019)Invicro, A Konica Minolta Company Apr 2019 - Mar 2020London, United KingdomSupporting Invicro's Hammersmith facility through an extended period of medical leave. -
Quality Systems Team ManagerGsk Jan 2014 - Dec 2017Worthing, West SussexResponsible for the Batch Release and ongoing Quality Systems support for the Worthing Primary Operation I lead a team of 6 covering batch record review, material disposition, planned and unplanned change, validation and Quality KPIs. (Not complete - more things keep cropping up!) -
Site Change Control LeadGsk Jan 2008 - Dec 2013Worthing, West SussexResponsible for the site’s planned change system on the site I have lead the site’s implementation of the GMS process for Change Control (MaCC) and provided support and governance for this since it went live in July 2008. Additionally I have:• Developed and refined metrics for reporting on processes such as planned and unplanned change, lab throughput and above site quality reporting.• Provided QA support to validation activities in the Primary Value Stream and occasional support (as required) to Steriles VS and Orals VS. • Helped improve the robustness of the site’s validation processes through improving the procedures and templates used to define and document the validation process.
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Senior Qa ScientistGsk Jul 2006 - Dec 2007Worthing, West SussexAs part of the site Validation and Change Control team I provided QA support to the validation activities in the Primary (API manufacturing) facilities on site and supervised the planned change process for the Primary and Steriles operations. I also:• Developed and implemented the site’s reporting for the GMS Not Right First Time metrics, including participation in cross site groups to ensure common standards of reporting.
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Senior Qa ScientistGsk Oct 2004 - Jun 2006Worthing, West SussexA role split between operational quality support for the bulk steriles operation, SAP training & troubleshooting and site lead on unplanned change. During this period I:• Supported third party audits on site, in the areas above.• Investigated the feasibility of and proposed ways of working for making improved use of the SAP system including participation in multi-site groups.
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Senior Qa ScientistGsk Jan 2004 - Sep 2004Worthing, West SussexSeconded to the cross functional project team implementing SAP at the Worthing site I:• Developed and implemented the site system for managing unplanned change.• Supported other aspects of the project by developing training materials and ways of working across the business.• Prepared and delivered training and support to users in the go-live period.
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Qa Support Team LeaderGsk Feb 2002 - Dec 2003Worthing, West SussexLeading the team of QA staff responsible for the batch disposition, cGMP and validation compliance for sterile operations (both API and vial filling) on the site I have:• Introduced standardised processes for tracking and assessing process deviations.• Driven improvements to systems and SOPs to enhance cGMP compliance in preparation for an FDA PAI of the parenterals facilities. • Supported third party audits (including FDA) by managing the “war room” and presenting on areas of expertise.
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Validation SpecialistSmithkline Beecham May 2000 - Feb 2002Worthing, West SussexSeconded to a bulk sterile facility being expanded with new process streams to supply the USA, I have:• Carried out the chemical process validation for the major API produced.• Been responsible for ensuring that the documentation associated with the project meets the required standards and achieves its stated objectives.• Improved the systems for managing chemical and environmental quality data.
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Compliance OfficerSmithkline Beecham Aug 1996 - May 2000Worthing, West SussexLeading the team of QA staff responsible for the batch disposition and cGMP compliance of the non-sterile APIs manufactured on site I was responsible for:• Review of batch manufacturing records and batch disposition.• Auditing for cGMP compliance of the API plants and external suppliers.• Review and authorisation of manufacturing area SOPs.• Devising and implementing new procedures and ways of working to improve cGMP compliance.
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Qc Team LeaderSmithkilne Beecham Sep 1994 - Apr 1996Worthing, West SusssexLeading a team of analysts responsible for the QC assessment of APIs I was responsible for:• Routine quality control testing of raw materials and finished APIs.• Batch manufacturing record review.• Auditing of the API manufacturing areas for cGMP compliance.
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Qa ScientistSmithkline Beecham Sep 1991 - Sep 1993Worthing, West Sussex• Review of batch records, trending and reporting on quality and department performance.• Implementation of QA systems for document management.• Devised and implemented systems as part of a sitewide project to cut cycle time and WIP stocks by 90% for leading products.
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Analytical Development ScientistSmithkline Beecham Jul 1990 - Sep 1991Worthing, West Sussex• Assessment of the quality impact of planned changes and unplanned deviations in API manufacturing.• Analytical support for troubleshooting production and laboratory problems.
Ed Andrew Skills
Ed Andrew Education Details
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Business Administration And Management, General
Frequently Asked Questions about Ed Andrew
What company does Ed Andrew work for?
Ed Andrew works for Perceptive Inc.
What is Ed Andrew's role at the current company?
Ed Andrew's current role is GMP Quality Manager.
What is Ed Andrew's email address?
Ed Andrew's email address is ed****@****gsk.com
What schools did Ed Andrew attend?
Ed Andrew attended The Open University, The University Of Birmingham.
What skills is Ed Andrew known for?
Ed Andrew has skills like Gmp, Change Control, Validation, Quality System, Quality Assurance, Quality Control, Sop, Corrective And Preventive Action, Deviation Management, Microsoft Excel, Pharmaceutical Industry, Technical Writing.
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Edward Andrew
United Kingdom
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