Vidya Chatterjee

• Conducting comprehensive gap assessments and implementing remediation plans for various Quality systems, including facilities and equipment controls, material controls, production controls, packaging and labeling controls, laboratory controls, and Quality assurance controls.

• Expertly mapping current processes for audits, regulatory submissions, change management, deviations and CAPA management, technology transfer, and vendor assessment to identify areas for optimization and efficiency improvement.

• Developing strategic compliance responses for FDA 483 observations, specifically in the areas of biopharma, sterile, and oral products.

• Performing thorough assessments of cleaning procedures, investigations, and training programs to enhance capability building within the organization.

• Utilizing risk assessment methodologies to develop robust contamination controls strategies, ensuring data integrity, and conducting comprehensive reviews of clinical Quality Management Systems.

• Evaluating requirements and providing guidance for ANDA REMS (Risk Evaluation and Mitigation Strategy) programs.

• Conducting thorough reviews of submission dossiers and incorporating lessons learned to enhance future regulatory filings.

• Ensuring quality and regulatory compliance at sterile/non sterile manufacturing plants inhouse/vendors-API, drug products- oral solid,liquid,injectable,ophthalmic

• Implementing strategies and policies to be compliant with FDA and global regulations. Performing audits for compliance and improvements

• Qualifying and approving Vendors through risk assessments and audits. Having risk-based approaches for quality strategies

• Leading Management review meetings for KPI review and corrective actions

• Performing Data Integrity assessments to ensure manual and electronic records compliance controls

• Ensuring Contamination Control Strategy across all 6 compliance areas to mitigate risks

• Leading technology transfer projects for quality assurance and compliance

• Reviewing and approving plant and Corporate SOPs, protocols, reports as per updated regulations. Overseeing all plant QMS activities for compliance and timely closure

• Performing release and risk assessments for pharmaceutical and animal health shipments-oral solids,liquids, injectable in the Middle East
• Evaluating business partners and freight forwarders through audits and risk assessments
• Managing recall operations and escalating major product quality issues
• Providing comprehensive training on quality systems, deviations, complaints, change control, and shipment handling
• Ensuring quality oversight of suppliers and distributors through agreements, audits, and risk-based approaches
• Managing pharmacovigilance processes, including complaint handling, investigations, and corrective actions
• Enhancing quality management systems, streamlining shipment processes, and sharing expertise through conference presentations

• Participating/ conducting corporate audit, customer audits, vendor audits and review and completion of CAPA actions for API, raw materials, drug products- injectable

• Monitoring process and product compliance as per TGA/PIC(S), ICH, EU GMP regulations

• Leading consumables management project for gaps and improvements in process to achieve Quality compliance

• Vendor life cycle management through periodic reviews, audits and performance evaluation

• Handling customer complaints for investigation and appropriate CAPAs

• Leading discussions for quality systems readiness for regulatory inspections

• Leading global strategy discussions across cross functional team- R&D, Regulatory Affairs, Manufacturing, Quality assurance, Procurement, Medical and Business for registrations and launches of drug products

• Developing, planning and executing registrations and launches of products as per US FDA, EU GMP, TGA, IS0 13485, FDA 21 CFR 820 for Oral solid,liquid,Nebulizers, Metered Dose Inhalers, Spacers and Actuators in global markets

• Liaising with internal and external stakeholders to ensure appropriate support for projects as per production plans

· Directing and managing successful technology transfer strategies including process validations and method transfer between sites

• Initiating and directing capacity planning project to re-register products from different sites to meet increasing demands

• Warranting manufacturing as per GMP requirements including product release and compliance, deviations closure and corrective and preventive measures

• Ensuring GMP readiness for Regulatory inspections like US FDA, Health Canada, EU and TGA to achieve successful outcomes

• Collaborating with global teams in R&D, Quality, Regulatory, Procurement, Clinical, and Manufacturing to develop registration strategies aligned with patent status
• Driving process improvements based on quality reviews and risk assessments across bio studies, manufacturing, and registration processes
• Participating in GCP audits and providing compliance recommendations to ensure effective CAPA implementation
• Ensuring quality compliance for deviations through root cause analysis and effective corrective and preventive measures
• Leading end-to-end Bioequivalence projects, including licensing, protocol design, subject selection, study conduct, and report generation
• Managing resources and budget using MSP and Planview software
• Ensuring updated QA systems and GMP readiness for regulatory inspections
• Leading dossier review discussions for module 2- QOS and module 3 to meet global regulatory requirements

• Conducting GMP audits at contract manufacturing sites, ensuring the implementation of Quality Management Systems and compliance with regulatory requirements
• Performing batch review and release activities to ensure product quality and compliance with specifications
• Managing vendor qualifications through thorough evaluation of API, excipient, and packaging material suppliers, as well as contract manufacturing sites, using quality agreements, risk assessments, and review meetings
• Overseeing technology transfers and validations at various manufacturing sites to ensure smooth and compliant processes
• Playing a key role in the implementation of integrated SAP systems for Quality and Warehouse functions, ensuring effective utilization of SAP modules
• Resolving market complaints related to product quality, packaging, and labeling issues, and providing effective recommendations for improvement
• Managing Quality agreements for third-party manufacturers and vendors, ensuring clear expectations and compliance standards are in place

• Leading FDA-compliant GMP and GDP audits for contract manufacturing sites and warehouses.

• Resolving market complaints, including packaging, labeling, Pharmacovigilance-PV, and product issues.

• Managing technology transfer, validations, and batch releases at contract manufacturing sites.

• Ensuring robust documentation management and adherence to SOPs and validation protocols.

• Implementing effective deviations management with proper root cause analysis -RCA and CAPA.

• Preparing contract manufacturing sites for regulatory inspections and evaluating compliance.

• Analyzing raw materials, packaging materials, vitamins, minerals

• Calibrating instruments (Spectrophotometer, HPLC, GC, Polarimeter, Fluorimeter)

• Carrying out internal audits/self-inspections –TQM of regulatory and manufacturing as a part of internal audit team to address noncompliance activities and to ensure effective CAPAs are implemented

• Developing and validating analytical methods using HPLC, GC and spectrophotometer as well as titrimetric

• Preparing and maintaining SOPs, validation protocols and reports as per ICH standards