Mervyn Martin Email & Phone Number

Management of Site Tech Transfer activities incorporating the manufacture of Feasibility, Phase III & NDA Submission batches for oral & inhalation drug delivery. Responsibility for pre-validation and validation activities and Process Optimisation.

Process Development, Investigation of Process Deviations, Technical Transfer, Installation & Operational Qualification, Process Validation Cleaning Validation, Technical Writing, Batch Record & Recipe generation. SOP Writing

Generate & Ensure compliance with Technical Services KPIs & Scorecard, Develop Annual Training Plan, Develop Skills Matrix,Implementation of a Continuous Professional Development Programme, Control & Issuance of Technical Services Documentation - TSBMRs, Recipes & In-Process Test Sheets)Site Lead for BSE/TSE Programme

Supervision, Recruitment, Training and Performance Management of staff. Lead Auditor for Vendor Quality Audits, Creating and maintaining Vendor Audit Schedule. Measure quality performance of key vendors. Completion of Annual Product Review.Sustainable Compliance Initiative Project - Implementation of Quality Systems for: Master Batch Records and Batch Release, Laboratory Operations, Critical Processing Aids, Annual Product Review, Supplier and Contractor Qualification, Manufacturing… Show more Supervision, Recruitment, Training and Performance Management of staff. Lead Auditor for Vendor Quality Audits, Creating and maintaining Vendor Audit Schedule. Measure quality performance of key vendors. Completion of Annual Product Review.Sustainable Compliance Initiative Project - Implementation of Quality Systems for: Master Batch Records and Batch Release, Laboratory Operations, Critical Processing Aids, Annual Product Review, Supplier and Contractor Qualification, Manufacturing, Packaging and Labelling, Components and Raw Materials. Show less