Sujit Shire
Liverpool
Summary
Accomplished CSV and Qaulity professional with expertise in software and laboratory equipment validation, leveraging strong interpersonal and communication skills to excel in team environments. Proficient in SDLC, CSA, GAMP, and quality risk management, with a proven track record in maintaining computerised systems compliance and ensuring data integrity. Committed to advancing career goals by driving innovation and maintaining high standards of compliance within the industry.
Overview
18
18
years of professional experience
6
6
years of post-secondary education
Work history
CSV Specialist (Quality)
Teva Pharmaceuticals
Runcorn
11.2023 - 05.2025
- Executed CSV quality review on documents produced by laboratory and manufacturing operations teams in accordance with internal procedures, corporate and regulatory guidelines (21CFR, EU Annex 11).
- Addressed CSV-related queries daily, targeting system gaps to ensure compliance.
- Carried out meticulous inspections of system maintenance documents such as Periodic Reviews, Disaster Recovery Plans, audit trail risk assessments, etc.
- Facilitate CSV quality support and supplier assurance for computerised systems.
- Administered CSV related QMS records operations involving change controls, deviations, and CAPAs within Trackwise.
- Contributed to Global Regulatory Authority Inspection Readiness for computerised systems.
- Developed CSV assessment template and standard operating procedure for new system validation.
- Performed Data Integrity Risk Assessments at both operating system and application tiers.
- Provided regular updates to CSV Manager and Senior CSV Specialist, ensuring project goals were met.
CSV Officer (Validation Team)
Rosemont Pharmaceuticals
Leeds
03.2022 - 10.2023
- Facilitate validation of computerized systems in accordance with GAMP and regulatory guidelines.
- Executed periodic reviews on computerised systems employed in laboratory, regulatory, pharmacovigilance, and quality alongside cloud-based infrastructure. Periodic Review on 10 high risk systems completed within 3 months.
- Developed and implemented test scripts for GxP computerised systems in collaboration with lab SMEs, business owners and QA
- Updated functional risk assessment to incorporate lifecycle activities, including upgrades and audit observations.
- Managed SAP change controls by engaging with external SAP validator and development teams.
- Created CSV assessment document and SOP while delivering CSV training materials.
- Engaged in addressing issues impacting system compliance
- Review document workflows for Trackwise Digital system (Salesforce based QMS platform)
- Direct report to CSV Specialist with cross-functional reporting to Validation Manager
- Facilitated smooth communications between departments for better coordination.
Equipment Compliance Scientist – Level 2
Eurofins PSS
Moreton
09.2020 - 03.2022
- Assessing calibrations and maintenance records documented by engineers for variety of instruments, lab equipment ans computerised systems.
- Managed elogbook platform utilised for instrument breakdown, maintenance, and calibration.
- Preparation of IQ, OQ documentation and decommissioning protocols for laboratory systems.
- Championed data compliance and integrity, focusing on audit trails and user rights.
- Facilitated situation appraisals for quality events concerning calibration and maintenance of lab equipment.
- Ensured precise system setups/configuration through application of GAMP principles.
- Delivered on-site Cybersecurity training leveraging client resources
- User experience with Empower, Tiamo, OMNIC and tools such as Elogbook and Symyx.
Scientist 3
Eurofins PSS
Moreton
08.2018 - 08.2020
- Provided analytical support for synthetic chemistry and early-stage analytical methodologies.
- Utilise Symyx electronic lab book to document experimental details
QCL Analyst
Elanco Ltd
Speke, Liverpool
02.2018 - 08.2018
- QC release testing (Potency and ID testing using HPLC) for animal healthcare products following strict GMP guidelines.
Scientist
Itaconix Ltd
Deeside, North Wales
10.2017 - 01.2018
- Engaged in establishing titration method to evaluate decarboxylation value of polymer.
Scientist
Allergan Biologics
Speke, Liverpool
03.2017 - 09.2017
- Execute method transfer, optimisation, and validation activities in-house utilising DIONEX HPLC system with Charge Aerosol Detector.
- Conduct in-process testing of biological samples
HPLC Specialist
AstraZeneca (MedImmune)
Speke, Liverpool
03.2015 - 02.2017
- Performed analytical methods transfer processes for monoclonal antibody products targeting European markets.
- Exhibited hands-on expertise in operation of Capillary Isoelectric Focusing (ICE 3 analyser), Bioanalyser, HPLC 1260 with Empower software, and GC 7890B.
- Compendia testing expertise, including osmolality and sub-visible particle analysis.
- Utilised internal documentation systems including AZ Doc, Trackwise, and AZ learning management system.
- Compiled validation documents for instruments utilised in method transfer.
Analyst (Inhalation pMDIs)
Pharmaserve Ltd
Runcorn
10.2012 - 02.2015
- Conduct analysis on raw materials, finished products, and stability samples utilising HPLC and GC in accordance with analytical specifications and pharmacopoeial monographs.
- Generation of stability reports, summaries, trending of stability data.
- Implemented lean system for HPLC column storage.
- Compiled qualification documents, including IQ/OQ protocols for lab equipment.
- Supported technology transfer and cleaning validation efforts for pMDIs.
- Trained team members in pMDI techniques such as Anderson Cascade Impaction and Total drug content etc.
Analytical Chemist
Almac Sciences
N.Ireland
09.2011 - 06.2012
- Conducted analysis of APIs and intermediates using HPLC, GC, DSC, spectrometry, FT-IR, and NMR for comprehensive compound characterisation.
- Supported phase I, II, and III clinical trial studies for APIs.
- Certification and commercial release of reference standards.
- Executed early-stage method development for API and impurity analysis employing conventional HPLC-PDA and UV-Vis rather than UPLC.
- Writing methods, generating specifications, management of QMS records within Trackwise
QC Analyst (Primary Production)
Norbrook Laboratories Ltd
N.Ireland
03.2010 - 08.2011
- Testing of API’s using variety of techniques which includes wet chemistry and chromatography techniques.
- Handling of Empower 2 software for HPLC analysis.
- Troubleshooting and maintenance of HPLC system.
Associate (Respiratory Technology)
Aptuit
Edinburgh, Scotland
08.2008 - 09.2009
- Conducting testing on dry powder inhalers for COPD and asthma in compliance with ICH conditions.
- Andreson Cascade Impaction.
- Stability testing of respiratory products as per ICH protocols.
- Performed validation activities such as intermediate precision, robustness, and linearity for DPI’s.
- Used Chromeleon software for the processing and interpretation of the data on HPLC.
Analyst (Contract)
Piramal Healthcare (Life Sciences)
Scotland
02.2008 - 05.2008
- Performing in process UV assays on antibody drugs conjugates.
- Size exclusion and reverse phase chromatography of conjugates on HPLC 1100 with Chemstation software.
- Gained the knowledge of protein chemistry.
Analyst (MSc Project)
Piramal Healthcare
Morpeth, North East England
06.2007 - 08.2007
- Project Title: Development of stability indicating method for the drug Hydroflumethiazide using forced degradation study (stress testing) carried out in Piramal Healthcare, Morpeth, Northumberland and Department of Biomedical Sciences in Strathclyde University.
- Instruments used Agilent 1100 HPLC system with Chemstation software and Mass Spectrometry for characterisation of degradation products.
Education
Executive Diploma - Computer System Validation
Institute Of Good Manufacturing Practices India (IGMPI)
Liverpool 06.2021 - 12.2021
MSc - Pharmaceutical Analysis
University of Strathclyde
Glasgow, Glasgow City 09.2006 - 09.2007
Bachelor of Pharmacy - Pharmaceutical Sciences
Amravati University
Amravati 06.2001 - 06.2005
Skills
- Interpersonal Skills
- Communication Skills
- Team Player
- SDLC
- CSA
- GAMP
- Internal Audit
- Quality Risk Management
- Data Integrity
- Cloud-based applications
- Software Validation
- Laboratory Equipment Validation
- Computer Systems Validation
- SAP and LIMS Implementation knowledge
Custom
- Networking
- Exercising
- Music
Affiliations
- Previous Physical Trainer at HSS UK (2023-24)
- Trained in Indian Classical Music upto level 4
- Amateur Guitarist
Languages
English
Upper intermediate
Accomplishments
First Prize in Adults Category in Table Tennis (Organised by Bolton Hindu Forum July 2024)
References
References available upon request.
Timeline
CSV Specialist (Quality)
Teva Pharmaceuticals
11.2023 - 05.2025
CSV Officer (Validation Team)
Rosemont Pharmaceuticals
03.2022 - 10.2023
Executive Diploma - Computer System Validation
Institute Of Good Manufacturing Practices India (IGMPI)
06.2021 - 12.2021
Equipment Compliance Scientist – Level 2
Eurofins PSS
09.2020 - 03.2022
Scientist 3
Eurofins PSS
08.2018 - 08.2020
QCL Analyst
Elanco Ltd
02.2018 - 08.2018
Scientist
Itaconix Ltd
10.2017 - 01.2018
Scientist
Allergan Biologics
03.2017 - 09.2017
HPLC Specialist
AstraZeneca (MedImmune)
03.2015 - 02.2017
Analyst (Inhalation pMDIs)
Pharmaserve Ltd
10.2012 - 02.2015
Analytical Chemist
Almac Sciences
09.2011 - 06.2012
QC Analyst (Primary Production)
Norbrook Laboratories Ltd
03.2010 - 08.2011
Associate (Respiratory Technology)
Aptuit
08.2008 - 09.2009
Analyst (Contract)
Piramal Healthcare (Life Sciences)
02.2008 - 05.2008
Analyst (MSc Project)
Piramal Healthcare
06.2007 - 08.2007
MSc - Pharmaceutical Analysis
University of Strathclyde
09.2006 - 09.2007
Bachelor of Pharmacy - Pharmaceutical Sciences
Amravati University
06.2001 - 06.2005
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