John Croall Email & Phone Number

Cambridge, Gb

Somerset, Nj, Us

Guildford, Surrey, Gb

Hemel Hempstead, Hertfordshire, Gb

OutlineWorking independently or within project teams; reporting to the technical manager. Provision of routine and non-routine support of the manufacturing facility to ensure revenue generation via product integrity and batch release as required. Key Responsibilities• Product lifecycle management. New product introduction and validation. Periodic revalidation of legacy products. Direct support of live manufacturing process and equipment issues. Validation of raw material changes.• Root cause investigations, CAPAs. Identification / execution of process improvements. • Responsible SME for multiple products and equipment. Performance of product scale up and transfers, validation, clinical and commercial manufacturing supply. Involved with development activities prior to scale up and transfer for continuity and scale ability.• Creation of manufacturing documentation, validation protocols, technical reports, SOP’s Risk assessments, gap analysis, FMEA.• Working closely with planning, quality, safety, engineering, analytical labs and production.• URS generation, equipment purchase and validation. Key Achievements include:o Successful validation of multiple API source changes, for multiple products.o Successful scale up and transfer of a new product.o Validation of semi-automatic tablet testing system (GAMP 4)

OutlineOne of two shift managers reporting to the senior manufacturing manager. Ensure achievement of revenue targets via schedule adherence and management of 21 work centers and up to 65 production staff working over a continental 4 shift system. Key Responsibilities• Effective prioritization of live equipment and process issues, exception reporting, investigations and CAPA’s. Effective interaction with all supporting functions; including QC, planning, QA, engineering and technical support.• Staff level maintenance: personnel interviews, personnel training and development. Performance reviews, implementing disciplinary processes as required.• Ensure safety is number one priority in the highly pressurized fast moving environment.• Key Achievements include:o Achievement of financial targets (EBITDA) and production schedule requirements both years of £12.4 million and £13 million respectively.o Identification and resolution of an equipment compressing issue impacting a priority product and amounting to turnover in excess of £250,000 per week.

Hemel Hempstead, Hertfordshire, Gb

OutlineBring a new build, class A drug manufacturing facility on line as per project plan. Reporting to the Operations manager. Efficient, cross-functional interaction ensured project success.Key Responsibilities• Perform all necessary SAT and validation activities on building facility and equipment.• Interview, selection, training and development to build a specialist team of 6 in preparation for product manufacture, with ongoing supervision, appraisal and development of team members.• Write all necessary production operation procedures, training documentation, operational and safety procedures. Compliance with Safebridge level 3.• Perform time mapping and schedule routings. Tracking and trending of API and process yields for Home office annual returns.• Identification / resolution of project and safety related issues. • Demonstrated total commitment to the execution and delivery of all project activities in line with the PMP. Overcame numerous issues / challenges encountered with equipment, utilities, manufacturing process and labour in order to deliver objectives. • Key Achievements include:o Selection and training of a first class team.o Providing leadership and drive such that product transition to commercial supply was seamless and on time with all project requirements successfully delivered.

Provision or lead of technical support to European third party manufacturers or global, Abbott manufacturing facilities for a range of products throughout lifecycles. Activities may have incorporated: New product support in collaboration with R&D NCE's (lean process development, scale up and transfer into commercial facilities and clinical manufacture), according to challenging deadlines. Product redevelopment, process improvement, strategic product transfer of legacy products. Experience in Process capability / control, CQA / CPP definition. Preparation and execution of technical reports / engineering studies / stability / equipment qualification protocols / Pilot-scale protocols and documentation. Routine review / update of local procedures / risk assessments. Master-manufacturing documentation modifications (within regulatory constraints). Review of international technical documentation. Training of global, technical personnel on processing, and associated techniques. Training and assessment of colleagues on local procedures and equipment operation. Intern supervisor (including job interviews / candidate selection). Management of pilot plant facility: Overseeing personnel and activities within the pilot plant. Plant and equipment maintenance including engineering / contractor / supplier liaison. Selection and purchase of new equipment; subsequent, installation, upgrades, validation and service contract tenders. Responsible for ensuring DSEAR (ATEX) safety within the pilot facility.Publications: Journal of Pharmacy and Pharmacology (British Pharmaceutical conference), Sciece proceedings 2008, supplement 1. Article 71: Sodium Calcium Alginate as a matrix component of modified-release dosage forms: an evaluation of raw-material source change.

Job roles and responsibilities are reflective of senior pharmaceutical technician but at a junior level. Skills and technical ability required to work independently are developed in this job role.Key achievements include:Consistent achievement in real time technical support (C.I) for remediation of commercial manufacturing issues in Europe. This role ensured product integrity, quality compliance and timely market supply of several products. Authored international Quality guideline document concerning Inspection of attributes and initiated similar document for intermediate product hold times for European, third party manufacturers.Significant contribution toward development of an immediate release Artesunate formulation, recognized by GPO President's award.

Trained in various commercial manufacturing equipment and techniques, utilizing both manual and computerized systems.Shift compression specialist - used for processing new and problematic products. Shift leading hand. Member of product initiation and process optimization team. Member of managerial communication steering committee. Well versed in GMP, COSHH, Health and safety at work, Class A. Additional duties: Forklift driver, first aid, shift, work permit issue.

Oil field drilling / exploration. Down-hole surveys for directional drillers and engineers using Tensor steering tool probe (wet / dry connection systems). Giro and gamma logging, cable splicing. Tools / Instrument testing, maintenance, winch operation. Liaison with rig and directional engineers to facilitate well drilling operations.

Dispensing operations, high / low shear granulation, particle size reduction, blending forklift driver, GMP.

Higher National Diploma, Chemistry

City & Guilds, Trades Certificates / Engineering