Posted:11 hours ago|
Platform:
Work from Office
Full Time
-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
Lupin
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