Experience

East Midlands Pharma

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Quality Manager

  • Oct 2021 - Present



3M

• United States
• Industrial Machinery Manufacturing
• 700 & Above Employee

• Senior Quality Assurance Engineer

  • Mar 2020 - Aug 2021

• Advanced Quality Assurance Engineer

  • Aug 2017 - Mar 2020

  • Final Release to Market for Medical Device Products• Quality approver on Quality investigations, Process Deviations, CAPAs, BOMs • Quality approver on Complaint Investigations • Quality Lead on various manufacturing and filling lines• Quality Lead at time of Validation of medical device filling line• Management of Regulatory Inspections• Audit Host for BSI Inspections• Internal Auditor • Author of various site QA procedures• Good understanding of Eudralex Volume 4, ISO13485 and ISO9001• Knowledge of a broad range of processes/ departments on site• Day to day use of various systems such as SAP, CATSWeb,

• Quality Assurance Engineer

  • Jan 2016 - Aug 2017

  • Final Release to Market for Medical devices on site• Quality approver on Quality Investigation, Process Deviations, CAPAs, complaint investigations.• Author of various site procedures• Global SOP standardisation for Quality related procedures• Management of Validation Master Plan• Excellent organisational skills from management of Regulatory audits (MHRA, FDA, BSI) • Good understanding of Eudralex Volume 4, ISO13485 and ISO9001• Knowledge of a broad range of processes/ departments on site• Product knowledge acquired on all products manufactured at Loughborough 3M Site

• Complaints Analyst

  • May 2015 - Dec 2015

  • Management of complaints received which consisted of logging, testing, analysing results and then reporting back to customer.• Monthly review and trending of complaints resulting in introduction of Corrective and Preventive Actions • Excellent time management skills obtained due to weekly tracking of complaint due dates• Strong communication and interpersonal skills developed during interaction with customers• Product knowledge acquired in Solid dose, Liquid & Creams, and Inhalation products

• QC Analyst

  • Nov 2010 - May 2015

  • Implemented and championed GMP/GLP standards and principles within the laboratory area.• Awareness of current regulatory standards as applicable to laboratory functions.• Performed analytical testing with minimal deviation in order to meet scheduled timelines.• Completed laboratory investigation reports with the outcome of implementing CAPAs to prevent further deviation.• Equipment owner; Responsible for the maintenance, calibration and validation of laboratory equipment.• Document Controller; Responsible for maintaining all documents within department and ensuring that correct versions are in circulation. • Provides support / technical expertise to resolve problems with analytical testing. • Supports continuous improvement activities within group.



Vectura Group

• United Kingdom
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Scientist II

  • 2006 - 2010

  • Author study protocols, standard operating procedures and technical memorandums to support continuous research. • Understand the importance of complying with regulatory authorities (EMEA, MHRA and FDA). Aware of and abide by the ICH guidelines and European Pharmacopeia. • Testing of various dry powder inhalers; reservoir, capsule and blister formats for development and stability studies in line with departmental procedures. • Evaluate trend analyses of data from stability and development studies and document findings in a final report through collating a wide range of information to establish final formulations. • Health and Safety Coordinator: Point of contact within the site, chair of H&S meetings, perform monthly audits of the site and report findings. Author of various H&S documents adhering to HSE regulations. • Transfer of scale up processes / technologies to overseas CMO and training staff in manufacturing / analytical techniques. Performed review process on BMRs prior to quality review. • Attended various external and internal training courses including product development “molecules to market”, statistics and Good Manufacturing Practice (GMP). • Participated in preparation for FDA and MHRA audits.



ILS Ltd Laboratories

• Leading Scientist

  • Aug 2005 - Sep 2006

  • Development and validation of suitable analytical methods. • Testing of various compounds using advanced analytical instruments, integrating results and producing results to set requirements, within a GLP environment. • Development and validation of suitable analytical methods. • Testing of various compounds using advanced analytical instruments, integrating results and producing results to set requirements, within a GLP environment.