Sunny Modi

Sr Manager - Corporate Quality at Althera

Based in Bengaluru, India

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Seniority

Manager

Department

Other

Location

Bengaluru

Industry

Pharmaceutical Manufacturing

Company size

194

Contact information

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Email

1 credit

s•••••••@altherapharma.com

Phone

5 credits

+91 ••• •••• ••••

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Background

About Sunny Modi

Pharmaceutical Quality professional with 15.0 years of work experience in non-sterile and sterile dosage forms. Having managerial skills and more than 22 persons directly reporting for various functions of Quality Assurance (QA) such as; Quality Management System (Change Control, Event for Incident / Investigations, CAPA and effectiveness checks, OOS/OOT, Atypical Investigation, Market Complaint etc.), Handling of In-process Quality Assurance (IPQA) Team, Batch Manufacturing & Packaging Record, Cleaning Validation, Process Validation, Hold time study, Product Quality Review / Annual Product Quality Review (PQR/APQR), Audit and Compliance, Risk Assessment, New SOP drafting and preparation, GAP assessment, Certified Approved Trainer, Self-inspection, Affiliates Audits and solving query / response in compliance and sustainable manner, Batch Release, Continued Process Verification (CPP/CQA/CMA), Control Sample Management (RM/FP) etc- Audit / Visit various sites of loan license manufacturing (LLM/P2P/CMO) as per schedule and ensure compliance of the sites.Quality software handling - Trackwise®, Documentum®, SAP, Qedge, ProcessXE - eBMR, Caliber LIMS, CARA, ERP etc.

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