Experience

Porton Biopharma Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior QA Deviation Specialist

  • Mar 2019 - Present

  o Senior QA specialist role created allow me to continue the contract position below. After the restructure within QA, I currently hold the role of as a hybrid of QA manager, senior QA and PQM under a QA manger as be part of team providing QA support for QA, QC, logistics and Microbiology groups and training for the other members in addition to my responsibilities as routine QA such as the review of GMP documentation such as validation reports, qualifications, scientific studies etc. o Initially hired to provide expertise and training in the investigation, interpretation and closure of deviations, OOS and other QMS systems to all levels of QA and across the further site and to identify and instigate improvements in the handling at every level of the deviation process and to aid in audit preparation. Along with driving updates to the deviation system I provided training in investigation, deduction, RCA tools and SMART CAPA and other subjects to QA and other departments as needed Show less



NICHOLLS QUALITY CONSULTANTS LTD

• United Kingdom
• Industrial Machinery Manufacturing

• Quality Consultant

  • Sep 2016 - Apr 2020

  Running Quality Consultancy across a number of contracts. Running Quality Consultancy across a number of contracts.



Zimmer Biomet

• Bridgend

• Contract Microbiologist

  • May 2017 - Nov 2017

  o Six-month contract to provide Microbiological/ QC expertise as part of a small specialist team to provide assistance in Audit preparation. o To improve the processes, handling and interpretation of environmental monitoring, bioburden and other test results. o Provide expertise in the investigation and interpretation of deviations (CAPA) and to identify and instigate improvements in the handling at every level of the deviation process. o Conduct validation reviews of both purified water systems and the controlled environments. Lead the documentation and planning around the instillation and validation of the new purified water system. Show less



Pfizer

• Based at Havant

• Contractor Operations Quality Assurance

  • Oct 2016 - May 2017

  o Seven-month contract working as part of a multi-national team to assist in the onboarding of Hospira’s global contract operations structure into the Pfizer network. o Coordinating and documenting the transfer of the legacy Hospira (L-HSP) vendors from the L-HSP regional groups to the relevant national AQO groups. o Revising the legacy Hospira Quality Technical Agreements (QTA) to ensure contractor specific controls and compliance requirements are maintained but also that they are in-line with the appropriate Pfizer standard template. o Coordinating the update and standardisation of the Quality Technical Agreements across the global COQA biopharma groups to establish a standard version. o Facilitate the transfer and integration of the L-HSP contractor’s annual product review system into compliance with the Pfizer COQA requirements while ensuring that all existing KPI and deadlines are met. o The generation and maintenance of several trackers to measure progress within the different system updates, ensuring their completion and disseminating the statistics and KPI across the teams. o Building a relationship with all of the individual CQL’s across the EMEA and American groups to better provide understand their requirements and provide answers and solutions. o Provide microbiological knowledge in the analysis of microbiological deviations for content and accuracy. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CAG Quality & Compliance Manager

  • Jan 2015 - Jul 2016

  To work as part of the above site Compliance Audit group, taking responsibility for conducting an independent assessment for all site Critical Deviations, Local Incident Committee (LIC) and Product Incident Review Committee minutes to: •Ensure that the reviewed deviations/complaints have been carried out as per the local SOP in addition, ensuring their compliance with both and global procedures. •Determine that the investigation was adequately documented and was carried out to the appropriate scope and depth, in an empirical manner. •Determine that the scope documented within the investigation covers all impacted batches and that satisfactory controls were put in place to manage the disposition of the batches. •Review the thoroughness that the true root cause is identified and that adequate supporting evidence is provided, providing guidance on corrective actions/information required to cover any deficiencies. •Assess the appropriateness, robustness of the corrective and preventative actions (CAPA) and are not only effective but also in-place and being sustained. •Identify and investigate any discrepancies within the investigation findings. To schedule and conduct meetings to: •Discuss any areas of clarification or concerns with the QP/Subject matter expert (SME) as required. •To provide feedback and critique around the deviation investigation/documentation. To provide reports which provide: •A list of deficiencies and/or risks identified along with recommendations for corrections. •An assessment of the adequacy of the evidence to support the conclusions of the report. •An impact assessment of any identified deficiencies. •Identify recommendations to improve the deviation reports, investigation and management process. Statistical Analysis: •The statistical analysis both to highlight patterns within the data and to drive improvement. •The summarisation and presentation of data to answer complex questions. Show less



Allergy Therapeutics

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Microbiologist IV

  • Jun 2014 - Nov 2014

  • Carry out routine/non-routine microbiological testing including LAL endotoxin, bioburdens and biological indicators. • Raising, investigating and completing Change controls, deviations and trend reports. Also providing approval and assistance to deviations, OOS and investigations carried out within the department. • Provide specialist knowledge on GMP compliance and test regimes. • Carry out routine/non-routine microbiological testing including LAL endotoxin, bioburdens and biological indicators. • Raising, investigating and completing Change controls, deviations and trend reports. Also providing approval and assistance to deviations, OOS and investigations carried out within the department. • Provide specialist knowledge on GMP compliance and test regimes.



Alliance Boots

• QC Micro Team Leader

  • 2012 - Jun 2013



Pall Corporation

• United States
• Manufacturing
• 700 & Above Employee

• QC Microbiologist

  • Sep 2011 - Jan 2012

  Physical and microbiological testing of pharmaceutical grade filters. Environmental Monitoring of laboratory area's. Equipment Preparation/ autoclaving. Physical and microbiological testing of pharmaceutical grade filters. Environmental Monitoring of laboratory area's. Equipment Preparation/ autoclaving.



Biocaldol LTD

• Microbiologist

  • Nov 2010 - Feb 2011

  Working as part of a mixed team of academics to contribute to and support the research project. * Design of processes and experiments to evaluate methods of continuous fermentation. * Production and development of bacteriological media/solutions to optimise ethanol production. * Support the genetic modification of thermophilic bacteria. * PCR testing of modified strains to determine presence of inserts. * Developed document control hierarchy and increased the level of control for the laboratory documentation, SOP's and processes. * Growth studies for modified strains. * Developing procedures for the identifying the effects changes in media/strain has on bacterial viability and condition from gram stains and identifying patterns indicating potential causes. * Management and maintenance of strain library. * Development, evaluation, scale up and transfer of concepts to fermenter. Show less



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• MEA Microbiologist

  • Dec 2005 - Jun 2010

  Expert in Microbial identification - Successfully Ran the microbiological identification laboratories for 3 years. Responsible for planning, training and supervising of staff as required. *Improved efficiency and safety by instigating (KPI (key performance indicators) programming the necessary spreadsheets to obtain the data, providing feed back to thedepartment and monthly to senior management. Using the data to Identify / predict problems or weak points that needed improvement or more resources.*Sampling and testing of water samples*Isolation and identification of microbiological isolates using microscopy, API and other tests.*Writing, training out and maintaining a range of SOPs and ensuring compliance with global and regulatory guidelines and policies. *Analysis, reviewing, approval and reporting of results. *Led and played a key part in investigations, deviations, out of specification and atypical results.* Expert in the KQCL analysis of samples for the presence of Endotoxin.* Validated/ qualified of a wide range of KQCL material test methods covering GMS and novel BioCEDD chemicals and intermediates including biological products.* Physical and microbial monitoring for production monitoring and certification of clean room environments and associated facilities. * Creation of a Environmental Monitoring trend database to automatically check data for errors, highlight possible OOS and to produce monthly reports.*Archiving of paperwork/ files as per document control policy.*Creation and maintainance of an Environmental Monitoring trend database to automatically check data for errors, highlight possible OOS and to produce monthly reports and presenting the dataduring site quality meetings, highlighting potential problems or developing trends. Show less

• QC Microbiologist

  • Apr 2004 - Nov 2005

  Environmental monitoring of production areas* Microbial testing of water for TVC and specific pathogens* Microbial testing of products for bioburden and specific pathogens* Sanitisation and validation of utilities/process streams.* Chemical analysis of water for metals, nitrates, T.O.C. and conductivity* Immunological testing of water and products for endotoxin (KQCL/gel clot)* Microbial identification (API and Vitec)* Analysis and reporting of results



GSK Biologicals

• QC Microbiologist

  • Oct 2009 - May 2010

  Nine month placement to provide knowledge on clean room certification, environmental monitoring and microbiological techniques as part of GlaxoSmithKline's pandemic response. * Flexibility in work hours and the ability to work independently was essential to this role especially during 24-48hr filling runs. * Water sampling and testing (potable, WFI and purified) Nine month placement to provide knowledge on clean room certification, environmental monitoring and microbiological techniques as part of GlaxoSmithKline's pandemic response. * Flexibility in work hours and the ability to work independently was essential to this role especially during 24-48hr filling runs. * Water sampling and testing (potable, WFI and purified)



GSK (Beckenham)

• MEA Microbiologist

  • 2005 - 2010



TML

• Veterinary Microbiologist

  • Jul 2003 - Jan 2004

  Isolation and identification of micro-organisms from samples of veterinary origin. * The immunological analysis of serum samples for parasitic organisms and viruses (ELISA and agglutination) and there improvement. * Developed procedures for the isolation and identification of Legionella from water, environmental and condensate samples increasing the versatility of the company. * Predictive ordering of consumables and equipment to maintain stock but to limit Isolation and identification of micro-organisms from samples of veterinary origin. * The immunological analysis of serum samples for parasitic organisms and viruses (ELISA and agglutination) and there improvement. * Developed procedures for the isolation and identification of Legionella from water, environmental and condensate samples increasing the versatility of the company. * Predictive ordering of consumables and equipment to maintain stock but to limit



Matco Leisure

• Assistant Manager

  • Nov 2002 - Jul 2003

  Day to Day management of a public house. Management of 19 - 22 staff including hiring / firing, wages and performance reviews. Ordering of stock. Day to Day management of a public house. Management of 19 - 22 staff including hiring / firing, wages and performance reviews. Ordering of stock.