Alan Wesley Email & Phone Number

Kirkham, Gb

Kirkham

Bought Pharmacovigilance (PV) functions in house, implemented PV Quality Management Systems and safety database.Case processing including data entry, review and assessment of SAE/AE reports (including narrative writing) from post marketing sources onto the global safety database (Argus), in accordance with company SOPs and regulatory requirements. Management of Change Controls, Deviations, RCA, CAPA’s and measurement of effectiveness.Maintain the oversight of audits and regulatory inspections.Performing 3rd party/partner auditsSupport the timely production and quality and authoring of the Pharmacovigilance Safety Master File.Authoring, reviewing and maintenance of SOP’s.Authoring, reviewing and oversight of Annual Safety Reviews and Periodic Safety Reviews.Authoring and maintenance of Safety Data Exchange AgreementsTraining of M & A Pharmachem personnel.

Bolton, United Kingdom

Management and career development of 20+ QC personnel within a solid dose manufacturing site.Responsible for the management of the QC laboratory, QC Stability, IPC laboratory functions and associated Quality Management SystemsRisk assessing data integrity and implementing strategies to ensure data integrity across the business.Management of the QC Stability Department and the staging of new products and established products in compliance with ICH guidelines.Responsible for review of raw material, finished product, stability data and key laboratory reports.Providing laboratory support for New Product Introductions, method validation and method transfer exercises. Analysis of reports, measurements and external benchmarks to identify opportunities for continuous improvement.Accountable for maintaining compliance of the laboratory in accordance with EU GMP/MHRA regulation.Leading laboratory investigations and raising/implementation of associated deviations and CAPAs.Authoring and reviewing of analytical methods, SOP’s and validation protocols/reports.Report of KPI’s, metrics, and weekly tasks to senior management.

Preston, United Kingdom

Responsible for a team of around 10 analytical chemists and the testing of liquid dose pharmaceutical products & consumer products in a FMCG environment.Review and communication of all raw data and analytical reports generated by the QC Lab in compliance with cGMP requirements.Planning and scheduling workload of the laboratory to tight deadlines ensuring stock is released to market on time.Maintain documentation including procedures, methods, specifications, certificates and related documents.Ensuring calibration routines are maintained and adhered to.Ensuring that personnel are trained in required procedures & practices.Management of laboratory investigations.Communication to suppliers, customers and resolution of customer complaints.

Ashford, Kent

Analytical chemist responsible for the analysis of cosmetic raw materials and ensuring that the quality of materials is assessed according to global and local quality procedures.Laboratory representative chosen to liaise with GMP implementation team as Coty Ashford strives to implement cGMP across the manufacturing facility in accordance with the EN ISO 22716 cosmetic directive.Raw material testing and batch release.Colour matching of raw materials and finished product.

Senior scientist leading a team of four scientists providing analytical support for active pharmaceutical ingredient manufacture within the Pfizer WR&D pilot plant. This includes testing and release of raw materials, in-process control samples, intermediate, API samples and cleaning verification samples. Experience in the use of many analytical techniques e.g. HPLC, GC, IC, PXRD, FT-IR, NMR, KF, HPLC-MSProficient in the use of Symyx ELN, LIMS and Empower for chromatographic data handlingResponsible for creation and development of the FT-NIR trending model used for the monitoring of API drying processes. This project led to a 30-40% reduction in API dryer cycle times and a decreased exposure of pilot plant technicians to active pharmaceutical ingredient.

Maidstone

Responsible for the purification of high value enzyme products utilising a variety of large scale chromatographic techniques. Also responsible for performing quality control assays (by UV) at key stages in processing.

2:1 B.Sc (Hons), Chemistry

2:2 B.Sc (Hons), Process Biotechnology