Shiv Gupta Email & Phone Number

Maastricht, Li, Nl

Reykjavík, Capital Region, Iceland

 Responsible for handling of various QMS tools such as change control, deviation, CAPA, OOS, OOT, investigation, RCA, risk assessment, regulatory compliance, and gap assessment to ensure identified quality risk is proactively mitigated to ensure compliance with GMP standards and regulatory guidelines. Active participation in various regulatory inspections and compliance monitoring. Accountable for site reference material management, analytical method transfers to CTL’s and business partners, and elemental Impurity testing for various Biosimilar products. Reviewing of various GMP documents as per regulatory guideline expectations. Supporting in CTD/ BLA/ ANDA review & regulatory query response. Support to RA for submission of dossier’s to various regulatory authorities

Pune, Maharashtra, India

 Focused on Quality system development, implementation, and improvement for Biologics DS and DP manufacturing facilities to ensure robust quality systems. Managed all quality-related operations to ensure that system & processes are in compliance with SOP, cGMP and CMC regulatory standards. Responsible for providing expert QA guidance for change control, deviation, OOS, OOT, market complaint, Investigations, root cause analysis, quality risk assessment, CAPA & documentation. Developed key quality metrics & KPIs against strategic quality goals and conducting trend analysis. for system performance. Responsible for higher management communications regarding significant quality, compliance issues to ensure prompt and effective resolution. Acted as the primary quality SME with cross functional teams for streamline communication and collaboration. Hosted regulatory inspections and presented site Quality systems. Responsible for escorting regulatory Inspectors during opening meeting, plant tours, documentation review and closing meet. Drafted CAPA responses & tracked compliance to ensure timely closure of regulatory commitments. Analyzed compliance data, identifying trends and opportunities for improvement, and advise leadership team through insightful metrics. Supported in preparation of contamination control and manufacturing process control strategy document for DS and DP facilities to ensure end to end microbial and sterility assurance. Reviewed and approved product specifications, SOPs, BMRs, BPRs, process validation, cleaning validation, stability protocol/report, batch records & analytical records. Ensured QA presence in manufacturing & testing areas through regular GAMBA walks. Audited global GMP and supplier manufacturing facilities in multiple countries, enhancing supplier quality management. Responsible for hire and development of QA talent, setting performance goals aligned with site objectives and fostering team growth.

Mumbai Area, India

 Developed proficiency in handling of deviations, change controls, CAPA, OOS and market complaints related to finished products. Developed a comprehensive understanding of Biopharma operations, including cleanroom setup and functionality. Acquired knowledge in biologics Drug Substance and Drug Product manufacturing. Supported validation efforts for manufacturing equipment, including Design Qualification, Installation Qualification, Performance Qualification, and Operation Qualification. Assisted in the preparation of Validation Protocols and Reports. Gained experience in equipment cleaning validation and hold time studies. Conducted in-process monitoring for Monoclonal Antibody manufacturing, ensuring compliance with batch record and written procedures.  Participated in technical training that enhanced understanding of products and processes, acquiring essential technical knowledge. Performed shop-floor monitoring to ensure GxP at all manufacturing stages of Upstream and Downstream. Managed IPQA for Biologics across all stages, including USP, DSP, Formulation, Filling and Packaging and supporting activities. Coordinated technology transfer from R&D to production and between production and CMOs. Managed CMO’s, ensuring adherence to Quality Agreements and serving the single point of contact for quality issues. Handled the internal audit and client audit program, encompassing audit scheduling and execution of through internal audits. Handled supplier qualification activities like, review of supplier documents (CoA, ISO, technical dossier, Specifications), analytical, microbial & biological testing data & preparation of qualification report. Managed quality incidents including supplier complaints, change notification, deviations etc. Presented vendor metrics, APQR trends, and quality risks at quality meetings & governance forums. Coordinated shipment validation and reviewed of transport documents for commercial and clinical batch supplies.

Mumbai Area, India

 Routine IPQA visits in manufacturing areas to monitor and ensure manufacturing operations are carried out as per SOP and batch production records.  Area line clearance in warehouse and manufacturing areas. Review of executed batch records, SOPs, various GMP protocol & report. Participated in regulatory inspections, and customer audits. Supported remediations. Managed creation/ revision, tracking and maintaining of supplier audit schedule, audit reports, quality agreements and change notifications. Conducted regular In-Process Quality Assurance (IPQA) inspections within manufacturing, ensuring adherence to SOPs and batch protocols. Verified completion of essential batch documentation checks against CoA, including deviations, change control, and batch records, to confirm compliance before batch release. Handled the implementation of audit corrective and preventive actions (CAPAs), to ensure effective resolution and prevention of quality issues.

Master Of Science - Ms, Biotechnology, A

Master Of Business Administration - Mba, Operation Management, First Class