Srikanth Varma Kc
Director - EPD Division Supplier Quality at Abbott
- Role
- Director - Epd Divison Supplier Quality at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Srikanth Varma Kc
An accomplished Quality & Compliance professional with 20 years of experience in Pharmaceutical & Medical devices industries. IRCA Certified Lead Auditor ISO 13485 (Medical Devices Quality Management Systems). Currently working as Lead auditor responsible for plan, conduct and closure of Raw material, finished product (OSD, Injectables and Biosimilars), and Third-party manufacturers for Abbott. Performed nearly 200+ audits across different countries. Profound knowledge of GMP aspects of pharmaceutical and device industry. GMP Auditor for APIs, Formulations, Excipients, CMOs, CROs, and packing materials. Experience in USFDA, EMA, TGA, CANADA, PMDA and other regulatory agencies audits. Experience in working for technical documents preparation and review of Biologics/Biosimilar products filings in US and EU markets for combination products. Experience d in working for technical documents preparation and getting approvals for 510K and CE mark for medical devices. Expert in developing, implementing and inspecting policies, standards and procedures for scientific work and technical work in the department or project technical projects
Experience
Director - Epd Divison Supplier Quality
Jun 2025 — Present · IN
Responsible to manage supplier quality across the globe for India, APAC, LATAM, METAP, Europe and other regions.Drives with dedicated and efficient team to deliver organisations objectives. Decisions making in daily operations by working with cross functional teams across globe to ensure safe and quality products are delivered by Abbott to its patients.
Education
Sri Krishnadevaraya University
Bachelor's degree, Chemistry, Microbiology
1999 — 2002
Sri Krishnadevaraya University
Master's degree, Microbiology, General
2002 — 2004
Ravindra Vidyaniketan high school
High School/Secondary Diplomas and Certificates
Skills
- Technology Transfer
- Instructor-Led Training
- Crisis Management
- Iso 13485
- Standard Operating Procedure (Sop)
- Deviations
- Change Management
- Iso 11608
- Validation
- Quality Assurance
- Quality by Design
- Pharmaceutics
- Computer System Validation
- Pharmaceutical Industry
- Sop
- Fda
- Microbiology
- Gxp
- Quality Auditing
- Medical Devices
- Capa
- External Audit
- Compliance
- Risk Assessment
- Fmea
- Vendor Management
- Glp
- Risk Management
- Business Impact Analysis
- Quality Control
- Medical Device Directive
- Gmp
- Regulatory Affairs
- Cleaning Validation
- Quality System
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