Sujanie Thileepan
Oxfordshire
Summary
Detail-oriented CSV Quality Assurance Advisor with strengths in regulatory compliance and data integrity. Ensures 100% adherence to global standards through comprehensive audits and robust validation processes. Drives continuous improvement by identifying compliance gaps and implementing effective remediation strategies.
Overview
7
7
years of professional experience
Work History
CSV Quality Assurance Advisor
Pharmaron
Rushden, Northamptonshire
08.2024 - Current
- Serve as the QA lead for Computerized System Validation (CSV) and Data Integrity (DI), ensuring 100% alignment with global regulatory standards including FDA 21 CFR Part 11, EU GMP Annex 11, GLP, and GCP.
- Execute risk-based audits of complex GxP systems, identifying critical compliance gaps and partnering with stakeholders to implement robust remediation strategies.
- Assess validation lifecycle documentation including User Requirements Specifications (URS), risk assessments, validation plans, and acceptance test plans, ensuring completeness, traceability, and regulatory alignment prior to approval.
- Review CSV Acceptance Test Plans, test scripts, and validation deliverables, verifying that validation activities are executed in accordance with approved procedures and industry best practices.
- Perform detailed audit reviews of CSV test reports and change controls, ensuring that test execution, deviations, and outcomes are accurately documented and fully traceable to raw data.
- Support deviation investigations, applying structured root cause analysis methodologies and ensuring appropriate CAPA (Corrective and Preventive Actions) are defined, implemented, and tracked to closure.
- Provide timely and transparent reporting of audit findings to Responsible Persons and senior management, facilitating prompt resolution of compliance risks and continuous improvement.
- Ensure data integrity principles (ALCOA+) are embedded within CSV processes, with a focus on accuracy, consistency, and reliability of electronic records and systems.
- Review and validate GxP-critical spreadsheets and electronic systems, ensuring compliance with CSV requirements, appropriate access controls, audit trails, and validation documentation.
- Support and oversee change management activities, ensuring all system changes are assessed for impact, appropriately documented, and validated prior to implementation.
- Utilise TrackWise Digital for Document Management System (DMS), Electronic Quality Management System (eQMS), and Training Management System (TMS) processes, ensuring effective quality and compliance oversight.
Quality Assurance Advisor
Pharmaron
Rushden, Northamptonshire
10.2020 - 07.2024
- Regulatory Compliance: Ensured all site projects strictly adhered to GMP (Good Manufacturing Practice) standards for both API and IMP, maintaining a state of inspection readiness.
- Document Auditing: Conducted rigorous audits of GMP documentation, including stability studies, Certificates of Analysis (CoA), and method verifications, ensuring 100% accuracy and data integrity.
- Process Inspections: Executed timely project inspections and critical phase audits (BMRs and analytical methods) to verify total alignment with SOPs and authorised protocols.
- Investigated deviations and quality events, driving root cause analysis and implementation of effective corrective and preventive actions (CAPAs).
- Collaborated with cross-functional teams (QC, Chemistry, and Management) to resolve production issues, enhance process efficiency, and support continuous improvement initiatives.
- Contributed to process improvements that enhanced operational efficiency and supported on-time project delivery.
Pharmaceutical Operator Specialist
APTUIT
Milton, Abingdon
09.2019 - 09.2020
- Part of a shift team synthesising active pharmaceutical ingredients (APIs) for mid-phase drug development on a pilot plant scale.
- Operate the pilot plant reactors and ancillary equipment following all the current procedures (IOPs, BPGs, etc.) to maintain high standards of safety, housekeeping, hygiene and quality.
- Documented and reviewed multiple reactor BATCH/VESSAL production guides (BPG and VCG) and cleaning guide (RCG) to ensure correct procedures are followed and any deviations are recorded to the cGMP standard, prior to formal review by Quality Assurance.
- Working with Quality Control and Quality Assurance to complete processes with the aim to achieve production improvements and/or to rapidly solve production challenges.
- Perform In-process control (IPC) sampling analysis to determine the assay of by-product and impurities using HPLC and NMR and the water content using Karl Fischer titrations.
- Complete routine maintenance and re-configuration to reaction vessels and ancillary equipment to ensure production is carried out in a timely and safe manner, complying with Health and Safety obligations.
- Support environmental monitoring and record of information.
Education
BEng Chemical Engineering - 2.1 Upper Second Class Honours
Loughborough University
07.2019
GCE Advanced Levels - A2: Mathematics (B), Chemistry (B), ICT (Distinction/lili), Business Studies (Distinction/lili)/li/ul
Harris Academy Purley
Purley07.2016
Skills
- TrackWise
- Microsoft Office
- AutoCAD
- Maple
- MATLAB
- Simulink
- Problem Solving
- Teamwork
- Leadership
- Communication
Timeline
CSV Quality Assurance Advisor
Pharmaron
08.2024 - Current
Quality Assurance Advisor
Pharmaron
10.2020 - 07.2024
Pharmaceutical Operator Specialist
APTUIT
09.2019 - 09.2020
BEng Chemical Engineering - 2.1 Upper Second Class Honours
Loughborough University
GCE Advanced Levels - A2: Mathematics (B), Chemistry (B), ICT (Distinction/lili), Business Studies (Distinction/lili)/li/ul
Harris Academy Purley