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ANJALI SHARMA

@anjalisharma23

Quality Manager at Teva Pharmaceuticals, managing global product complaints and quality oversight for external manufacturing.

India

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At TEVA PHARMACEUTICALS EXTERNAL MANUFACTURING AND SUPPLY OPERATIONS (EXM), through STROTUS CORPSOL, I manage product technical complaints in Veeva Vault QMS for pharmaceutical products, medical devices, and combination products made by external manufacturing partners.

I review site investigations, assess root causes and CAPA adequacy, and follow complaint trends using statistically derived alert and action limits. I also support assessments for authority notifications and US FDA Field Alert Reports.

At GLENMARK PHARMACEUTICAL LIMITED, I investigated market complaints for semisolid preparations and prepared quality risk assessments using FMEA, Fishbone, and 5 WHYs. I also developed and analyzed Continued Process Verification reports using Minitab.

Earlier, at TEVA API INDIA PRIVATE LIMITED and CORAL DRUGS PRIVATE LIMITED, I worked on deviations, OOS results, supplier quality monitoring, audits, and product quality reviews. I also taught pharmacy subjects as a Guest Lecturer at R.S.M COLLAGE OF PHARMACY.

Experience

Work history, roles, and key accomplishments

Current

Quality Manager

Current

Teva Pharmaceuticals

Oct 2025 - Present (1 year)

Managed product technical complaints end-to-end in Veeva Vault QMS for pharmaceutical products, medical devices, and combination products, ensuring compliance with cGMP and corporate standards. Led global quality oversight for commercial products at CMOs and drove ExM quality projects.

Veeva Vault QMS CAPA Root Cause Analysis Complaint Management Regulatory Compliance GMP FDA Regulations EMA Risk Assessment Trend Analysis Pharmacovigilance Serialization Traceability Project Management Gap Analysis SOPs Quality Systems

Guest Lecturer

R.S.M College of Pharmacy

Jan 2025 - Sep 2025 (8 months)

Delivered lectures and practical sessions in pharmacy subjects as per PCI curriculum, prepared lesson plans, and mentored students. Conducted examinations and ensured laboratory compliance.

Teaching Curriculum Development Mentorship Laboratory Compliance SOP Adherence PCI NAAC Academic Audits

Officer – Quality Assurance

Glenmark Pharmaceuticals

Feb 2021 - Mar 2023 (2 years 1 month)

Managed issuance and retrieval of analytical test data sheets and log books, initiated and reviewed Change Controls and CAPA, and investigated market complaints. Conducted quality risk assessments and developed CPV reports using Minitab.

CAPA Change Control Root Cause Analysis FMEA Fishbone 5 Whys Minitab APQR CPV Nitrosamine Risk Assessment Training Process Validation Technology Transfer Regulatory Audits GMP

Quality Specialist – Quality Assurance

Teva API India Private Limited

May 2019 - Sep 2020 (1 year 4 months)

Oversaw issuance and retrieval of analytical test data sheets and batch records, led investigations of OOS results and deviations, and performed root cause analysis. Reviewed change controls and conducted internal audits.

CAPA Root Cause Analysis OOS Deviation Management Change Control FMEA Fishbone 5 Whys PQR Trend Analysis Internal Audit Supplier Quality Nitrosamine Risk Assessment GMP 21 CFR Part 11

Officer – Quality Assurance

Coral Drugs Private Limited

Sep 2016 - May 2019 (2 years 8 months)

Prepared and reviewed SOPs, oversaw batch records, and investigated market complaints for APIs. Conducted quality risk assessments and reviewed stability data and audit trails.