Hemangkumar Kalavadia
Mumbai
Summary
Accomplished Head of Quality with 18 years of experience in the pharmaceutical industry, specializing in third-party and contract manufacturing operations. Demonstrated success in CMO Alliance and Monitoring across India and Southeast Asia, ensuring the country release of vaccines through effective advocacy with health authorities. Expertise in operational management, quality compliance, and project management has led to significant improvements in product quality and regulatory compliace while mitigating critical risks. Committed to leveraging leadership skills to enhance manufacturing operations and foster continuous improvement within teams.
Overview
15
15
years of professional experience
Work History
Head-Quality
Sanofi
Mumbai
04.2023 - Current
- Monitored and maintained quality standards across external manufacturing operations.
- Quality, Operational Efficiency projects through process simplification and standardization.
- Define and monitor KPIs to ensure the compliance status.
- Coordinated quality escalations for risk mitigation across SEA and Indian markets.
- Conducted due diligence processes to assess potential partnerships, and performed regular GMP audits of CMO partners.
- Lead the development of quality systems and processes to ensure product compliance with applicable standards.
Country Quality Manager
Sanofi
Mumbai
09.2021 - 04.2023
- Guaranteed adherence to quality standards within the Country Quality Organization for commercial quality.
- Manage country release activity for vaccine and biological products.
- Strategize the advocacy program and conduct an in-country analysis for imported products to ensure product availability and release after importation.
- Ensure distribution quality management.
- Management of recall at the country level and communication.
- Management of Not of Standard Quality (NSQ) declared by the health authority, if any.
- Management of counterfeit product complaints, and related communication and actions.
- Quality Event Escalation and Risk Management at the country level.
- Define, implement, manage, and control a country quality system for GxP and health-regulated activities, in compliance with Sanofi and local regulation requirements.
- Manage quality compliance for distribution activity.
- Product complaints.
Operational Quality Manager & Quality Auditor
Sanofi Healthcare India Pvt Ltd
04.2019 - 08.2021
- Ensure site readiness for regulatory inspection.
- Support the third-party manufacturing site in routine quality operational issues, approve investigations, and make operational decisions.
- Lead assigned improvement projects at third-party manufacturing sites.
- Track CMO KPIs, and apply an improvement plan where needed.
- Regular compliance visit of TPM sites.
- Perform GMP audits of other CMOs, RMs, and PM Suppliers as per the annual planner.
- Negotiated quality agreements with suppliers and customers to clarify expectations and responsibilities.
- Monitored changes in quality regulations and standards, updating company practices to maintain compliance.
- Provided leadership in developing best practices for continuous improvement initiatives across all departments.
Third-Party Manufacturing Quality – Manager
Sanofi Synthelabo India Pvt Ltd
04.2017 - 03.2019
- Ensure the Quality Compliance at various third-party manufacturing sites
Third-Party Manufacturing Quality – Manager
Boehringer Ingelheim India Pvt. Ltd
10.2012 - 02.2017
- Product Supply
- Ensure product supply form TPM sites as per monthly NRP plan
- Coordinate for PO release to TPM sites and ensure the product supply as per PO
- Coordinate with various departments at TPM sites for manufacturing as per plan
- Roll out monthly NRP based on Product SLA
- Monitor and ensure change implementation i.e
- Artwork changes, MRP changes
- Third Party Quality Operation and Project management
- Ensure the Quality Compliance at various third party manufacturing sites
- Roll out of global track wise system as SME for Audit CAPA management, complaint management, and deviation & CAPA management
- Perform and participate in periodic GMP audits of third party manufacturing sites, and to ensure audit CAPA timeline & its implementations
- Performing the data integrity checks periodically
- Technical support & Project management for technology transfer for solid oral, Injectable
- Handling of Market complaint and Recall Management
- Receiving of complaint, entering in to the track wise system, Investigation of the complaint, closure of complaint in the system and feedback to the complainant
- Tracking and trending of QMS KPIs including complaint, deviation, CAPA, etc
- Review and approving manufacturing and quality control gap analysis for technology transfer
- Handling of Product complaints
- Receipt, evaluation and investigation of complaints and final closure of complaint with in time frame
- Review of application and communication for the regulatory activity, review and compilation of product dossier
- Review & Approve product labels for compliance as per rule 96, 97 and schedule P requirements
- Label revision, Proofing and approval
- Prepare and Review of Quality Agreements (QAA) for CMOs, Warehouses and other GxP Service providers
Executive - Quality
Baxter India Pvt Ltd
11.2009 - 10.2012
- Learning of Lean Manufacturing Concepts for creating and sustaining Lean Culture
- Implementing 6S, Kaizen, Value Stream Mapping for Process Value added-Non Value added activity
- Qualification of plant expansion, Sterile facility
- Batch release, Sterile products
Cipla Ltd
- Ensuring the supply and quality of the product at various Loan licenses location from incoming of Raw material to the dispatch of finished goods
- Responsible for CMO management of sterile products sourced for India and export market
Intas Pharmaceuticals Ltd
- In process activity and document review
Education
Post Graduate Certification program - General Management
Indian Institute of Management (IIM) Nagpur
Pharmacy Graduate -
Sardar Patel University
GujaratSix Sigma Green Belt training certification -
Indian Statistical Institute (ISI)
DelhiGMP Lead Auditor -
Skills
CMO Alliance
- GMP Compliance
- Project Management
- Lead Auditor
- Lead Investigator
- Cogs Improvement
- Quality Agreements
- Product Launch
- Technology Transfer
- CMO selection & Due diligence
- SME for QMS workflow design
- People Management
- Power BI / Digital dashboards
- Microsoft
- Veeva for QMS
- Operational excellence
- Quality management systems
Languages
- English
- Hindi
- Gujarati
Personal Information
- Date of Birth: 11/04/84
- Gender: Male
- Nationality: Indian
- Marital Status: married
Education Training Certifications
- Post Graduate Certification in General Management, Indian Institute of Management (IIM) Nagpur, Distance learning program
- Pharmacy Graduate, Sardar Patel University, Gujarat
- Six Sigma Green Belt, Indian Statistical Institute (ISI) Delhi
- GMP Lead Auditor
Timeline
Head-Quality
Sanofi
04.2023 - Current
Country Quality Manager
Sanofi
09.2021 - 04.2023
Operational Quality Manager & Quality Auditor
Sanofi Healthcare India Pvt Ltd
04.2019 - 08.2021
Third-Party Manufacturing Quality – Manager
Sanofi Synthelabo India Pvt Ltd
04.2017 - 03.2019
Third-Party Manufacturing Quality – Manager
Boehringer Ingelheim India Pvt. Ltd
10.2012 - 02.2017
Executive - Quality
Baxter India Pvt Ltd
11.2009 - 10.2012
Cipla Ltd
Intas Pharmaceuticals Ltd
Post Graduate Certification program - General Management
Indian Institute of Management (IIM) Nagpur
Pharmacy Graduate -
Sardar Patel University
Six Sigma Green Belt training certification -
Indian Statistical Institute (ISI)
GMP Lead Auditor -
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