NEELESH GUPTA

- Lead Quality Assurance (QA) for routine Quality Management System (QMS) activities such as change control, audits, deviations, CAPA, and supplier qualifications.

- Oversee new product introductions and maintain the Quality Management System (PQS) for facilities. - Develop systems for quality management, equipment validation, and data integrity.

- Supervise manufacturing, manage audits, monitor compliance, and handle quality risk management.

- Conduct gap analyses of the QMS against EudraLex Volume 4, ICH guidelines, PIC/S, and the Orange Guide. - Coordinate batch release activities with the Qualified Person (QP) on GMP releases.

- Oversee QA during new facility construction, managing validation and change management.

- Guide teams on quality requirements and manage risks during technology transfer and process development.

- Support operational quality activities, ensuring inspection readiness and running control rooms. - Conduct pre-qualification audits for key suppliers to maintain an approved supplier list.

- Monitor Key Performance Indicators (KPIs) to assess QMS effectiveness and drive improvements, achieving over 90% compliance.

- Design quality reports to identify areas for improvement and enhance performance through targeted training, reducing nonconformity rates.

- Collaborate with cross-functional teams to streamline quality procedures and train employees on QMS processes.

- Identify gaps to improve business processes, policies, and workflows while managing resources efficiently.

- Oversaw and ensured that products complied with Product Specifications and relevant regulatory or industry requirements.

- Managed batch release process, internal audits, deviations, change controls, CAPAs, customer complaints, risk assessments, and investigations.

- Conducted quality audits to identify non-conformities and implemented corrective and preventive actions (CAPA) to address quality issues, resulting in a 25% reduction in defect rates. - Oversaw supplier management, including conducting supplier audits and implementing corrective actions to address non-conformities.

- Managed and implemented Quality Agreements along with relevant aspects of licensing and sourcing agreements as necessary.

- Participated in cross-functional teams to develop and implement quality improvement initiatives and global projects, including Veeva implementation and B-Corp certification.

- Established and maintained Key Performance Indicators (KPIs) to monitor the effectiveness of the Quality Management System (QMS) and drive improvement initiatives.

- Developed Internal Quality Standards, Quality Manuals, Quality Policies, Standard Operating Procedures (SOPs), and Work Instructions.

- Significantly improved site metrics related to overdue actions stemming from deviations, change controls, and risk assessments by driving timely action completion.

- Maintained detailed records of quality issues and resolutions, providing data-driven insights to support decision-making.

- Analysed quality trends and communicated findings to manufacturing and senior management teams to inform strategic decisions.

• Led, supervised, and trained the QA team and continuously improved the local quality system.
• Performed real-time review of batch manufacturing records, Environmental Monitoring records and Pharmaceutical Quality System (PQS) templates and supported QP product releases.
• Managed deviations, change controls, CAPAs and audit actions within a PQS and coordinated quality exceptions, microbiological out-of-trend and out-of-specification results and other environmental excursions.
• Led complex projects to the highest standard within agreed timelines. Involved heavily in setting up the vector production module, commercial production module and QC lab.
• Participated heavily in regulatory audits and acted as SME for Quality Management System and documentation processes at regulatory and external audits.
• Developed and maintained GMP standard operating procedures in accordance with regulatory and company requirements.
• Supervised implementation of Vineti-Cell Tracking System and Veeva system.
• Reviewed equipment and facilities validation and qualification protocols.
• Shaped quality systems, processes, and procedures to assure product quality and safety.
• Coordinated customer complaints and product recalls.
• Performed risk assessments (FMEAs) with respect to product quality and health & safety.
• Performed review of starting material and critical raw material suppliers, including audits.
• Generated and compiled monthly quality reports and metrics (KPIs) for the site.
• Conducted internal inspections by a defined schedule.

• Led, supported, and coached deviation investigations, including root cause analysis, FMEA, CAPA development, and impact assessments in Trackwise and SAP- MERP.
• Trained staff in analytical methods, processes, and established ways of working.
• Supported regulatory inspections (FDA, MHRA) and Level 2 audits.
• Checked and interpreted the analytical work performed in the laboratory to guarantee the work was accurate. Performed analytical assays using internal procedures.
• Prepared, reviewed, and updated GMP documents, including stability and release protocols, technical terms of supply, technical transfer reports, gap analysis reports, assay reviews, scientific documents, etc., to ensure compliance with regulations.
• Led implementation of LES (Laboratory Execution System).
• Actively contributed to continuous improvement initiatives, including developing and maintaining metrics for trends and key performance indicators (KPIs).
• Reviewed control system Validation Master Plans, IQ, OQ and PQ protocols and reports.

• Developed bespoke software solutions to meet specific business needs.
• Facilitated productive team meetings, fostering a collaborative work environment.
• Enhanced product quality to exceed customer expectations.
• Performed regular system backups, preventing potential data loss.

• Carried out day-to-day duties accurately and efficiently.
• Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.
• Successfully delivered on tasks within tight deadlines.
• Demonstrated respect, friendliness and willingness to help wherever needed.