Alexander White Email & Phone Number

Hatfield, England, United Kingdom

Hatfield, Hertfordshire, United Kingdom

Providing Qualification and Validation support with the following responsibilities:- Managing Eisai Manufacturing Limited's Validation Master Plan (VMP) and Validation Activities Schedule. As well as providing Qualitysupport for Validation and Qualification activities.- Reviewing equipment and process activities from project startup to closeout: including FATs, URS, IQOQ, PQ and process validation against cGxP and GAMP guidelines.- Supporting the QMS through the maintenance of Change Controls, Action Items, CAPAS and Deviations.- Providing support for the reporting of Key Performance Indicators.- Developing the Q&V strategy for a number of key projects such as Level 3 serialisation software, introduction of new packaging lines (primary and secondary) and associated utility and facility qualification, systems upgrades to on-premis e-QMS (TrackWise).- Supporting the implementation and validation for a Global Enterprise Resource System.- System administration of a GAMP Category 4 e-QMS (TrackWise).

Hatfield

- Ensuring EML’s Quality Management System (QMS) (TrackWise) and any associated systems used for the manufacturing, packaging, testing, storage and distribution of marketed drug products comply with cGMP requirements.- Supporting the effective running of the Product Quality Review (including authoring), Quality Agreements, Deviation, Parallel Imports, Risk Management, Qualification and Validation, Training, Standard Operating Procedures, Internal and External Audits and Approved Supplier Systems within Eisai Manufacturing Limited.- Providing quality oversight on Qualification & Validation activities. - Ensuring Qualification and Validation activities are in line with cGMP requirements for GAMP category 3 and 4 systems.

Stevenage, United Kingdom

- Providing exemplary customer service to all customers within the store resulting in extremely positive feedback on the online customer service questionnaire.- Carrying out large and complex business orders via the copy and print centre which required the execution of systematic quality control to ensure the customer received an outstanding service. - Working as a team as well as assigning roles and training new associates, demonstrating confident communication skills, leadership skills and the ability to work efficiently and effectively in a team based environment.- Showing numeracy skills when being entrusted to cash up and close the store at the end of the day.

Slough, United Kingdom

Following an industrial placement year within the Global Documentation Group at GlaxoSmithKline (GSK), I was asked to stay on as a GSK employee for a further three months until I resumed my final year at university to assist and provide guidance on the restructuring of the Global Documentation Group.In addition to the duties outlined in my Industrial Placement I also:- Organised and facilitated the training of new employees within the Global Documentation Group, which involved one-on-one training and regular review meetings both in person and using Skype.

Slough, United Kingdom

- Liaising with a number of business functions within R&D to support the development of documentation required for the validation and commercial manufacture of a wide range of products.- Managing the documentation of commercial products within an electronic documentation system – which includes review, electronic approval and issuing fully approved documents to manufacturing sites.- Interacting with R&D and/or Global Manufacturing and Supply (GMS) sites (both GSK and third part contractors) to implement approved change controls, including tele and video conferencing and travelling to the sites including R&D and GMS.- Reviewing and developing new Standard Operating Procedures (SOPs) within the Global Documentation Group.- Carrying out internal audits to ensure all SOPs are adhered to and to identify areas for improvement.

Bachelor Of Science (Bsci), Forensic Science, First Class Honours

Activities and Societies: Captain and Vice President of the Anglia Ruskin American Football Team 2016-2017. Member of the Anglia Ruskin.

A-Level, Chemistry, Mathematics, Physics

Activities and Societies: Student Science Ambassador

Gcse, 10 A*-C Including: English, Mathematics And Science