Tapan Kumar Panda

• Lead the overall Quality Assurance function for a greenfield facility handling High Potent solid oral and sterile injectable products. • Establish, implement, and maintain a robust Quality Management System (QMS) aligned with global regulatory expectations (USFDA, EMA, WHO, GCC and EDE). • Drive a strong quality culture across all site functions, ensuring compliance, ownership, and accountability. • Provide QA oversight for facility design qualification, equipment qualification (DQ, IQ, OQ, PQ), and process validation. • Ensure compliance with ASTM E2500, ISPE, ICH, and GAMP 5 principles for risk-based validation and commissioning. • Prepare the facility for global regulatory inspections and customer audits. • Build, train, and mentor the QA team to meet the demands of a complex sterile and High potent facility. • Foster cross-functional collaboration with Production, Engineering, QC, and Supply Chain teams. • Support technology transfer and product lifecycle management activities. • Provide input to senior leadership on risk management, quality governance, and compliance strategies.

• Lead Commissioning, Qualification & Validation (CQV) for biologics manufacturing (drug substance). • Prepare and execute protocols (FAT/SAT, IQ, OQ, PQ) for facility, equipment, cleanrooms, HVAC, and utilities. • Ensure project compliance with cGMP, ISPE, ASTM, and regulatory requirements. • Coordinate with multidisciplinary teams to ensure timely and compliant project delivery. • Support inspection readiness and documentation for audits

• Handled facility expansion project to enhance the production by 20 billion dosages(tablets/capsule) • Implemented risk-based validation strategies and managed PPQ and CPV activities for more than 30 new products introduced at site. • Directed validation and quality management systems across multiple product categories. • Led cleaning validation using ADE/PDE and toxicology-based approaches. • Spearheaded “Right First Time” documentation, enhancing compliance and reducing deviations. • Collaborated with cross-functional teams for regulatory readiness and continuous improvement. Successfully handled USFDA, EU-GMP, WHO and various customer audit .

• Spearheaded QA and Validation functions for a Greenfield OSD project, from design phase to regulatory approval. • Successfully established and qualified R&D, Manufacturing, QC, and Microbiology laboratories. • Designed and implemented site-wide Quality Systems in line with cGMP and global regulatory expectations. • Cleared GMP inspection by NMRA Sri Lanka, achieving compliance without major observations. • Headed the Development QA team to ensure quality oversight during formulation development and scale-up. • Led the timely compilation, review, and submission of product dossiers for regulatory approvals. • Initiated and managed Cephalosporin OSD and DPI Greenfield facility, aligning infrastructure with regulatory requirements. • Oversaw facility qualification, equipment validation, cleaning validation, and documentation readiness. • Fostered a strong compliance culture and trained cross-functional teams on quality systems and regulatory standards.

• Played key role in securing approval from Belarusian Ministry of Health for MAb facilities. • Managed QA/QC teams and all GxP activities across manufacturing and testing operations. • Led cleaning validation, equipment qualification, and compliance documentation. • Responded to regulatory queries and implemented effective CAPAs • Audited more than 10 API and finished dosage facility

• Led the QA and Validation department, ensuring regulatory compliance and audit readiness across all manufacturing operations. • Successfully managed and hosted regulatory inspections including USFDA, EU GMP, and multiple customer audits. • Ensured timely closure of audit findings and implementation of robust CAPAs for sustained compliance. • Conducted internal quality audits and implemented continuous improvement initiatives. • Oversaw the complete Quality Management System (QMS), including Deviation, CAPA, Change Control, OOS, OOT, and SOP management. • Delivered team training programs as per the defined training calendar to maintain inspection readiness and employee competence. • Directed qualification of equipment and facilities for Solid Oral and Oral Liquid dosage forms. • Managed qualification of cleanroom utilities including HVAC, Purified Water, Compressed Air, and other critical systems. • Supervised qualification of QC and Microbiology instruments, ensuring alignment with GxP standards. • Led Computer System Validation (CSV) activities in compliance with 21 CFR Part 11 and EU Annex 11. • Validated GMP modules of SAP (PP, WM, QM, PM), ensuring secure, compliant digital workflows. • Oversaw process and packaging validation for regulated markets including US, EU, and RoW. • Reviewed batch manufacturing records (BMRs) and provided technical guidance to manufacturing and QA teams. • Conducted product hold-time studies to ensure quality and stability over defined time frames. • Led cleaning validation for OSD and liquid dosage using risk-based ADE/PDE approaches. • Performed risk assessments for facility, equipment, and processes to ensure proactive compliance and safety.

• Progressed from Technical Trainee to Manager within 7 years, recognized for rapid learning, milestone achievement, and leadership. • Gained hands-on validation experience across diverse dosage forms—tablets, capsules, sachets, pellets, ointments, cytotoxic products, and injectables. • Led cleaning validation activities across 10 formulation units, ensuring robust compliance with EMA and USFDA requirements. • Implemented PDE-based acceptance criteria for cleaning validation per updated EMA guidelines, improving risk-based compliance. • Played a key role in FTO-3 and FTO-2 facility expansion projects, guiding team members through equipment and facility qualification. • Oversaw computer system validation (CSV) for process equipment software per 21 CFR Part 11 standards. • Authored and reviewed critical documents including Validation Master Plans, Cleaning Validation Master Plans, and SOPs. • Managed QMS activities including deviations, CAPAs, change controls, incidents, and investigations across validation and manufacturing. • Led root cause analysis (RCA) and CAPA implementation for system and process deviations. • Participated in the development of Quality Risk Management Plans (QRMP) for cross-contamination control in multi-product facilities. • Successfully represented the validation department during multiple internal, customer, and regulatory audits (MHRA, USFDA, TGA, WHO, etc.). • Trained and mentored team members across validation projects, contributing to department-wide capability building.

• Served as the central point of contact and leader for Cleaning Validation across all Dr. Reddy’s formulation sites in India. • Represented the validation team during major internal, customer, and global regulatory inspections. • Led the cross-contamination risk study for multiproduct facilities (FTO-03 and FTO-07) in collaboration with PharmaConsult, USA, implementing a robust contamination control strategy. • Directed validation and compliance efforts during the FTO-03 facility expansion and FTO-01 renovation projects, ensuring alignment with cGMP and regulatory standards. • Managed the requalification of the injectable manufacturing facility at FTO-01, achieving full compliance with evolving global guidelines. • Established harmonized cleaning validation practices across multiple sites, incorporating risk-based methodologies and toxicological data (PDE/ADE-based limits). • Collaborated cross-functionally with QA, Engineering, Manufacturing, and Regulatory teams to ensure consistent validation documentation and audit readiness. • Proactively supported audit preparedness and CAPA closure for Cleaning Validation across diverse dosage forms and facilities.

• Led the Qualification Team for the FTO-02 facility expansion project, ensuring timely execution of qualification protocols (URS, DQ, IQ, OQ, PQ) across equipment, utilities, and systems. • Headed the Cleaning Validation team, overseeing strategy, execution, and documentation across multiple dosage forms and facilities. • Successfully introduced and implemented “Residue” cleaning validation software for MACO (Maximum Allowable Carryover) calculations, improving accuracy and efficiency of validation reporting. • Represented the Validation function during regulatory audits by USFDA, MHRA, and other international agencies, with no major observations reported. • Streamlined validation documentation practices in compliance with EMA, WHO, and 21 CFR Part 11 guidelines. • Championed cross-functional collaboration to enhance audit readiness, technical reviews, and regulatory alignment in cleaning and qualification domains.

• Awarded the prestigious Young Bravo Award for outstanding performance and contributions to validation excellence. • Led cleaning validation activities at FTO-03, the largest multi-product manufacturing unit, ensuring compliance with global regulatory standards. • Executed comprehensive validation tasks including product contact surface area calculation, MACO calculation (using matrixing approach), and preparation of cleaning validation protocols and reports. • Coordinated cross-functional activities for swab sampling, testing, and result interpretation, ensuring accurate and compliant data for regulatory submissions. • Successfully managed the requalification of facility and equipment for the FTO-06 (Baddi) formulation site, covering OSD, Injectable, and Ointment manufacturing. • Ensured cGMP compliance during lifecycle requalification and documentation updates in line with global standards (USFDA, WHO, EMA).

• Led the execution of qualification activities for the FTO-03 facility expansion project, one of Dr. Reddy’s key generic manufacturing units. • Successfully qualified HVAC systems for cleanroom compliance, ensuring adherence to ISO and GMP classification standards. • Oversaw the qualification of solid oral process equipment, including granulators, tablet presses, coating machines, and blenders. • Ensured alignment of qualification documentation with cGMP, GAMP 5, and validation lifecycle principles. • Collaborated with cross-functional teams (Engineering, QA, Manufacturing) to meet project timelines and regulatory expectations.