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Pharmacy Award 2015
School of Pharmacy (SOP) University of London
BPharm Hons., Pharmacy, 2.1 specialising in Pharm-Eng-, GPhC registered
1991 – 1994
School of Pharmacy, University of London (Oct 1994 – Oct 1995)
Worked on Phd. For the company Capsugel (a subsidiary of Warner Lambert), who at the time produced 80% of the worlds hard gelatin capsules. I produced a in depth report on the liquid filling of starch capsules. The project was later shelved putting an end to my funding and hence the Phd.
Supervisors: Professor Mike Newton (School of Pharmacy) & Dr Ewart Cole (Capsugel Switzerland)
Activities and Societies: N/A
Industrial Pharmacist QA Specialist / Advisor in Pharm- Dev-
June 2014 – Present (1 year 1 month)Macclesfield
Appointed as Quality Assurance Advisor in Pharmaceutical Development department reporting to the Director of UK Quality Projects. A member of a team of 5 QA Advisors.
Regular duties Include:-
Conducting internal audits
Archiving clinical Batch Documents
Review and release of AZ and contractor manufactured clinical bulk dosage forms batch records
Review and release of AZ and contractor manufactured clinical API / drug substance batch records
Review and release of AZ Particle Size Reduced Drug Substance
Review and release of AZ and contractor packaged clinical bulk batch records
Liaising with pharmaceutical contractors regarding clinical batch related deviations and change controls
Liaising with CMC Regulatory with regard to Substantial Amendments to IMPD / IND / QOS etc....
Levelling and approving deviations in “Trackwise”
Managing CAPA’s in “Trackwise”
Checking, changing and approving material dispositions in “Clincopia” inventory system.
Creating Release documents in “GEL” and “ANGEL”
Writing, reviewing and approving SOP’s when required
Managing, updating Product Specification Files (PSF’s) for clinical trials
Representing QA on Pharmaceutical Development projects
Providing QA support to the API Large Scale Labs and the API Pilot plant.
Ensuring clinical batches are released on time and in a compliant manner.
Providing GMP advice to clinical API manufacturing and contractors.
Penn Pharmaceutical Services Ltd.
June 2013 – June 2014 (1 year 1 month)Tredegar, Wales, UK
Appointed as a Quality Assurance Specialist reporting to the site Senior Quality Operations Manager. Part of a team of 5 QA Specialists.
Three months of intensive training: Reading SOP’s, updating training file, shadowing various QA officers/ Assistants, understanding Clinical & Commercial production, packaging & labeling, understanding QP Certification & batch release processes & office documentation. The study of important QMS policies.
Key Tasks and responsibilities:-
Appointed QA point of contact for the new Contained Manufacturing Facility (CMF)
Supervision of all stages of solid dose manufacture in the CMF
Involved closely with New Facility (CMF) Start Up
Involved in sampling of Purified Water during Performance Qualification stage 1 of Purified water system
Regular hosting of client audits
Responding to Client audit observations
Supporting regulatory audits e.g. MHRA, FDA, ANVISA and the Turkish Authorities
Carrying out internal departmental audits
Carrying out EU GMP audits in Europe and the US of Suppliers prior to vendor approval. Writing up audit reports following audits.
Creating Certificates of Conformance and Certificates of Analysis for batch release
Writing new SOP’s for the Contained Manufacturing Facility
Reviewing & updating new & Old SOP’s via stand alone changes and Change Controls
Providing QA oversight of all Planned & Preventative Maintenance for the CMF
Having oversight of CMF
Providing Quality input into preparation of Batch Manufacturing Records / Batch Master Records
Supervision of all solid dose Processes such as Dispensing, Blending, Granulation, Extra Granulation, compression & coating.
Supervision of In Process Checks for stratified solid dose samples
Implementation special AQL checks for specific clients
Specials & Trials Release Pharmacist
Baxter International Inc.
November 2010 – July 2011 (9 months)Stockport, United Kingdom
Employed as a Pharmacist & QA Officer. Part of a team of 2 working in an aseptic compounding and steriles manufacturing unit. Reporting to the head of Quality for the unit.
3 months of intensive training in Baxter procedures and aseptic manufacturing processes.
Study of the site QMS & Merlin Part 11 compliant Inventory and labelling system.
Responsible for order review as a pharmacist
Responsible as a Pharmacist for batch release & PS release documentation for aseptically manufactured cytotoxic compounds & other oncology products such as MABs with all products being produced under a “Specials” Licence (MS).
As a QAO Collating microbiological data for head of QA e.g. settle plate CFU counts etc…
Experience of working with Orange Guide regulations concerning sterile products, cGMP/ GMP, GDP and GDistP.
Knowledge of Assured Sterility Levels & Parametric Release.
Experience of working with site specific / cross site SOP’s and work instructions.
Experience of documenting non conformances (Deviations) and implementing CAPA’s.
Experience of supervision of all the stages of aseptic manufacturing from assembly to post compounding inspection and beyond.
Knowledge of Isolator / Clean room technology,
regular verification of lab equipment such as scales, thermometers
Organising Calibration work to be carried out by External contractors.
validation of equipment e.g. qualification of main storage refrigerator
Process Validation e.g. the Sterilisation of Raw materials using the peroxide cycle.
Knowledge of the following dosage forms: infusions, infusors and injectables and sterile manufacture.
A good understanding of cytotoxic drug stabilities.
Involvement with Service Supplier Approval Programme.
QA sign off of New Product Approval documentation
Maintaining my knowledge base via ISO train.
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