Experience

Porton Biopharma Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Lead GxP Archivist and MasterControl System Administrator

  • Apr 2011 - Present

  I manage the PBL GxP Archive containing over a million records and am part of the Quality Systems management team. My responsibilities include: - Responsible for the security of the retained paper records and oversight of the Archive Facility and repositories. - Management of Archive policies and procedures. - Creating and maintaining a system to ensure the accessibility and retrievability of digitised records while maintaining required security of the records. - First line management responsibility for Archive staff (including one to ones, appraisals, training etc) - Interpretation and implementation of GxP regulations applicable to records within the archive catalogue. - Data input into computerised systems requiring a high degree of accuracy (relating to accessioning, retrieval, disposal etc). - Manage the provision of retained paper and digitised records to inspectors during Regulatory inspection (MHRA, FDA) and other audits. - Perform routine eQMS administration tasks including user, system configuration and security management - Manage and resolve technical and user issues, coordinating with site IT and MasterControl Technical Support to ensure timely resolution. - Assist with the development of system policies and other procedural documentation.



Public Health England

• United Kingdom
• Hospitals and Health Care
• 700 & Above Employee

• Validation Document Controller

  • Jul 2008 - Apr 2011

  - Operate and manage Quality Systems and Databases for the control of all validation documentation, for all divisions of HPA CEPR.- Manage validation documentation both entering and loaded from the pre-archive facility.- Facilitate the issue and control of Validation Plans in line with SOPs.- Maintain and update validation matrices, document status databases and requalification lists and align with Quality Management Review Board future expectations, eg change control and facilities validation.- Manage the Validation office, to include visitor and contractor security clearance, daily routine activities, supplies purchasing and general administration.- Act as critical interface for both internal and external audits and regulatory inspections.

• QA Documentation Officer

  • Jul 2005 - Jul 2008

  - Manage and prioritise the formatting and typing of Quality Documents (SOPs, Monographs, policies etc).- Manage the review process of Quality System Documentation using SOP the database.- Maintain the master set of paper documents, document indices and electronic document files.- Issue and distribute copies (controlled, uncontrolled specimen etc) of Quality Documents inc laboratory record books, logbooks and pharmaceutical product labels.- Liaise with internal customers to ensure the prompt receipt and recording of new issues of documents and withdrawal of obsolete documents.



QUALITY LIFT PRODUCTS LIMITED

• United States
• Appliances, Electrical, and Electronics Manufacturing

• Warehouse Administrator

  • Apr 2003 - Aug 2005

  Arranged lift and component deliveries, maintained component stock levels, invoiced storage and delivery charges, picked, packed and shipped component orders, arranged warranty returns to suppliers

• Component Administrator

  • Aug 2002 - Mar 2003

  Responsible for the sale of all component lift parts, quotations (ex stock and bespoke from European suppliers), order processing tracking and invoicing.

• Office Administrator

  • Mar 2001 - Aug 2002

  Coordinating the day to day running of the office, manned reception and telephone switchboard, filing for all departments.



MILLENNIUM PYROTECHNICS LIMITED

• United Kingdom

• Various Positions

  • Jun 1996 - Mar 2001

  Dispatch Coordinator - 2000/2001 season Mail Order Manager - 1999/2000 season Site Assistant - 1996-1999 Dispatch Coordinator - 2000/2001 season Mail Order Manager - 1999/2000 season Site Assistant - 1996-1999