Lupin
Select how often (in days) to receive an alert:
Sr. Executive - CMQA Date:
Jan 13, 2026
Company:
Lupin
Job Description
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
Work Experience Approx 9-10 years in CMQA
Education Post Graduation in Pharmaceutical Technology or Pharmaceutical Technology
#J-18808-Ljbffr
Sr. Executive - CMQA Date:
Jan 13, 2026
Company:
Lupin
Job Description
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
Work Experience Approx 9-10 years in CMQA
Education Post Graduation in Pharmaceutical Technology or Pharmaceutical Technology
#J-18808-Ljbffr