Ed Andrew Email & Phone Number

London, England, United Kingdom

London, United Kingdom

Supporting Invicro's Hammersmith facility through an extended period of medical leave.

Worthing, West Sussex

Responsible 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!)

Worthing, West Sussex

Responsible 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.

Worthing, West Sussex

As 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.

Worthing, West Sussex

A 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.

Worthing, West Sussex

Seconded 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.

Worthing, West Sussex

Leading 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.

Worthing, West Sussex

Seconded 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.

Worthing, West Sussex

Leading 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.

Worthing, West Susssex

Leading 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.

Worthing, 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.

Worthing, West Sussex

• Assessment of the quality impact of planned changes and unplanned deviations in API manufacturing.• Analytical support for troubleshooting production and laboratory problems.

Professional Certificate In Management, Business Administration And Management, General

Bachelor'S Degree, Chemistry, 2:2