Biocon Biologics Limited (BBL) is a unique, fully integrated leading global biosimilars enterprise that is committed to transforming patients’ lives and healthcare by enabling affordable access to lifesaving biosimilars to patients across the globe.My Responsibilities,• Responsible for implementing Quality System and Compliance for External Supply Quality function. • Develop and implement robust systems related to batch disposition in accordance with local regulatory and international requirements, including review of identified QMS.• Responsible for Product Quality Complaints Management, Review of Quality Technical Agreements.• Involve in product quality investigations, as necessary, based on the requirement.• To support any new/existing Product developments, regulatory submissions, queries and product launches.• Responsible for Quality Audits at CMO, co-ordinate with CMO and provide regular updates and performance of all CMO’s to the management. • To participate in review of Health Authority responses by co-ordinating with CMO’s • Ontime and regular escalations of all CMO’s performance to the management• To provide Metrics data of all CMO’s to the management• To handle Joint quality meetings and to handle business review meetings with all CMOs.• To interact with all Quality groups within organization and supporting implementation of harmonized approach across various quality functions

Viatris Inc (Viatris) is a global healthcare company, which develops, licenses, manufactures, markets and distributes generics and branded medicines, and consumer healthcare products. My Responsibilities,• Ensure the Global Biologics Manufacturing Sites and Contract Manufacturers are always in a state of compliance by enhancing/ fostering a Quality culture. - Collaborate with CMOs and affiliate sites to ensure compliance with Global, Regional and Local Health Authority / Regulatory Requirements and Expectations. - Participate and support for Regulatory inspections scheduled for the products manufactured for Viatris at the CMO sites. - Work with the Biologics Vertical Manufacturing or CMO sites by providing advise during the review and approval of HA responses, commitments, and periodic updates with a focus on Global compliance and consistency. - Support in addressing remediation activities at the CMO sites. - Help sites by providing SME support during critical investigations.• Ensure compliance at all CMO/Partner sites to have no supply disruptions; support all project and product launch timelines. - Work with integration teams on due diligence activities • Review compliance systems and establish an effective surveillance function in conjunction with GOA. - Establish appropriate metrics to help monitor both internal and external compliance and service levels that are relevant to the Biologics vertical activities.• Review and revise internal business processes to reflect current expectations and compliance requirements. - Collaborate with global operations audit groups and quality team members to perform independent verification of closed HA commitments i.e: In-place & In-use verification of HA commitments and to perform verifications of Quality Action System Actions.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare and providing 7 billion people access to high quality medicine.I was a part of Global Quality Compliance team and my key responsibilities were,• Lead in the development, improvement or maintenance of compliance requirements supporting corrective activities, Inspection readiness, and regulatory agencies (FDA) inspection management. • Participate and lead in internal/external audit and inspection preparation and management. • Manage remediation projects, sterility assurance projects, leading cross-functional teams. • Manage various source observations to assure corrective actions are implemented.• Ensure that the internal audit processes are conducted and that the corrective actions are implemented. • Responsible for a robust compliance monitoring system to ensure regulatory compliance on an on-going basis. Provides adequate tracking and oversight to any regulatory inspection commitments and ensures their timely closure.• Support the implementation and tracking of Key Quality Indicators. • Support maintenance and completion of the quality plan and local/global quality improvement initiatives• Facilitates the Deviation and Change Control Governance process at the sites.• Review the manufacturing, testing and other practices for compliance to the SOPs. Recommend corrective actions where necessary to ensure total compliance to cGMP requirements. • Actively manages the Compliance team and sets up their development and objective targets.

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.I was responsible for two sites and led the teams in successful commission, qualifications/validations, setting up QMS framework and regulatory submissions. Site obtained the initial approvals from various global authorities, including Europe, Australia during my tenure. I was extensively involved in remediation of quality systems and processes, across the organization including drafting the corporate level policies/procedures related to sterile manufacturing.

Fenwal, Inc. is a global medical technology company focused on transfusion medicine and cell therapies through unique expertise in blood separation, collection, filtration, storage and transfusion.I was working as Manager-Quality (Asia Pacific) and I was responsible for,•Acts as a quality representative for the Fenwal APAC business in accordance with applicable laws and regulations.•Establish quality systems and procedures to ensure conformance to local country norms and requirements.•Participate as required in regular business review meetings and ensure quality topics, KPI’s, and concerns are raised and discussed with Fenwal and third party site management. •Works with third party suppliers to ensure product quality meets Fenwal and all relevant cGMP and regulatory requirements.•Works directly with in country third party suppliers to resolve product related quality issues. (Customer Feedback)•Conduct periodic assessments of third party contractors/suppliers as requested by Supplier Quality.•Oversee the warehousing and distribution activities for Fenwal products to ensure compliance to the established quality system including where applicable authorizing the release of products for in-country distribution and destruction of expired or damaged goods.•Works with warehouse to disposition returned and/or damaged product in a timely manner.•Maintain knowledge and understanding of regulatory and quality requirements in country of responsibility and advise business of upcoming changes in the regulations.•Respond to inquiries from regulatory agency questions.•Support government tenders as needed to meet Quality requirements and provide documents as needed.•Participate in and respond to applicable agency inspections.•Assist sales when required to address customer concerns of product quality.

Baxter International Inc., is global healthcare company which develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. I was working as Associate Manager - Quality (Asia Pacific Support) and was responsible for,• Quality Management Systems and Procedures• Participating in Regulatory/Customer Audits and co-coordinating with the all the concerned depts. for response compliance as part remediation.• Conducting Internal Audits as per Regulatory Requirements and interaction with all concerned depts. for compliance.• Supporting in Compilation, review, responding and strategizing Regulatory submissions.• Review of all departmental SOPs, Batch Records, Protocols, Reports, Product Specifications.• Review of BMR and Release of Finished Products• Monitoring and ensuring compliance of various quality measures & cGMP norms during manufacturing and also co-ordination in preparation, checking, maintaining and updating documents as per cGMP norms and other Regulatory Requirements.• Organizing monthly Reviews, Quality issues with the concerned Depts, and drawing the action plan and compliance checking.• Planning for training gaps identification and training calendar• Submitting un-biased investigation summary with complete root cause analysis in problematic areas of manufacturing operations

Huons Global Co Ltd (Huons) is a pharmaceutical company that provides medical solutions for human health. The company which develops, manufactures and distribution of pharmaceutical products and medical devices.I was working as Quality Assurance Specialist and I was responsible for QA Activities / CTD Preparations and Review

Baxter International Inc., is global healthcare company which develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.My key responsibilities were,• Quality / System Implementation:- Corporate Quality Policies- Training of all employees as per schedules- Monitoring progress vis-à-vis target dates- On-going monitoring and suggesting remedial measures• Quality Training Activities• Supplier Quality Assurance:- Assessment / approval / training / rating to assist the purchase department- Inspection at supplier end- QMR-Local Evaluation• Monitoring of Quality System:- Annual Product Quality Review- Quality Management Review- Handling of Tier 1 and Tier 2 –CAPA System- Handling of Product complaints - Change Control System- OOS –Investigation, Root Cause Analysis, implementation of corrective and preventive actions and its effectiveness check- IPQA activities

Wockhardt is a global pharmaceutical and biotechnology organization which manufacture and marketing of Pharmaceutical and Bio-pharmaceutical formulations, Active Pharmaceutical Ingredients (APIs) and Vaccines.Key Responsibilities:•Analysis of Raw materials and Finished Products per Pharmacopoeias and In-house specifications.•Sampling of Raw materials, packing material, Intermediate and Finished Products.•Trend analysis of Raw materials and Finished Goods•Preparation of working standards prepared against pharmacopoeia Reference standards•Micro biological analysis-BET, sterility and other limit tests.•Updated WHO.cGMP Documentation and Maintaining Sop’s for Raw material, packing material and finished products.•Development of manufacturing and analytical procedures.•Implementation of standard operating procedures.•Inspection of manufacturing process and Quality Assurance activities.•Assistance to Export Documentation and registration in foreign countries.•Validation of manufacturing & Analytical methods.•Calibrating of all lab equipment and maintaining the data’s.