Devendra Khandelwal
Quality Professional | Masters in Pharma | Leadership | Pharma OSD, Sterile, Biosimilar | Transformation | Compliance & Excellence from Product Development to Commercial Manufacturing and Supply. Ex. GSK, Novartis, DRL.
- Role
- Senior Manager- Supplier Qa at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Devendra Khandelwal
Central Quality Professional with more than 16 years of experience into Global and Local Markets [Regulatory covering area of US-FDA, EU, PIC/S, ICH, WHO, ISO and FSSAI] of Pharma [Rx & OTC] and Consumer Healthcare [Nutrition and Food Supplement] products from Development, Tech Transfer and Commercialization distribution and supply in local and global markets. • Driving Quality improvement/System & Process upgradation/ Cultural improvement/ Remediation/ strategic Projects.• Working experience with Internal mfg. site, Development site, and External sites like CMO/TPM, API, Exp and Pkg material sites etc. for covering entire end-to-end product lief cycle of input material management to commercial supply & distribution quality management, oversight, issue management and support for continuity of business. • Experienced in Formulations like Oral Solid, Liquid, Sterile formulation, Semi-Solid and Powder.• Handled all type of QMS system like Deviation, Product Complaint, Investigations, OOS, and Change Control, Audit & Compliance for Global and cross-cultural sites.• Global and Regional procedure preparation or updation, inclusion of all regulatory requirement, and implementation.• Lead internal and external audits, ensuring adherence to quality standards and regulatory requirements.• Certified Auditor and 10 years of experience in auditing for Internal (Self-assessment and Internal audits) as well as external site like CMO/TPM, API, Excipient, Nutritional Material for local, global locations.• Due-diligence of CMO and Suppliers for new product development, tech transfer and launch in different geographies. • Establish key performance indicators (KPIs) to measure and improve quality performance metrics of TPMs/ CMOs and Suppliers. Quality oversight, Relationship management. • Good knowledge on TRACKWISE, EDMS, Darius, Veeva, SAP, ERP and other industry data base like RMS (Risk Management, ATOM (Project Management).
Experience
Senior Manager- Supplier Qa
Aug 2025 — Present · Mumbai, IN
Education
Rajasthan University, Jaipur
Masters, Pharmaceutical Chemistry
2006 — 2008
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