Sr. Executive - CMQA

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Date: Jan 13, 2026

Company: Lupin

• Review and authorize Master Batch Records, stability protocol, process validation protocol, temperature cycling protocol, specification of in-process, intermediate and finished products for US and IRF market at CMU.
• Release of batch manufactured for US and IRF market at CMU
• Handling of market complaint with root cause identification and CAPA implementation
• Review of documents such as executed BPR, Analytical records, Change Controls, Deviations, OOS, Process Validation, Cleaning Validation, Equipment Qualification, stability data and CAPA for products of US & IRF market.
• Provide required documents to Regulatory affairs for variations and updates
• Monitoring of process starting from dispensing to packing including witness analysis of LL/ MM/ TP products manufactured at sites for US & IRF market
• New product review to be carried out at manufacturing site after availability of all the documents.
• Provide monthly update to HO on CM sites under monitoring.
• Review & follow-up for effective compliance of observations made during day-to-day activities and audits conducted by CQA team.
• Review & implementation of Pharmacopeial changes for products.
• Routine / new site audit of CM location delegated by the Appraiser & prepare audit reports.
• Identification of Non-DCGI products and coordination with CM for regularization of Non-DCGI products.
• Implementation of common CAPAs across CM locations.
• Ensuring process and packing validation, stability analysis and transport validation (wherever applicable) of new products

Approx 9-10 years in CMQA

Post Graduation in Pharmaceutical Technology or Pharmaceutical Technology