Executive - Cqa [Immediate Start]

3 days ago


Bhavnagar, India LUPIN Full time

JOB Responsibilities - Location Ahmedabad 1 Ensuring the GMP compliance at CMO and Release of batch manufactured for US market at CMU 2 Monitoring of process starting from dispensing to packing including witness analysis of Lupin products manufactured at CMO for US market and Domestic market 3 Handling of market complaint with root cause identification and ensuring the CAPA implementation 4 New product review to be carried out at manufacturing site after availability of all the documents 5 Review and authorize Master Batch Records stability protocol process validation protocol temperature cycling protocol specification of in-process intermediate and finished products at CMU 6 Review of documents such as executed Batch Production Records Analytical records Change Controls Deviations OOS Process Validation Cleaning Validation Equipment Qualification stability data and CAPA for Lupin products manufactured at CMU 7 Provide required documents to Regulatory affairs for variations and updates 8 Review follow-up for effective compliance of observations made during day-to-day activities and audits conducted by CQA team 9 Review implementation of Pharmacopeial changes of products manufactured at CMU 10 Routine new site audit of CM location delegated by the Appraiser prepare audit reports review of compliance and ensure the closer of CAPA 11 Implementation of corporate CAPAs across CMO locations 12 Ensuring process and packing validation stability and transport validation wherever applicable of new products 13 Ensuring the implementation of quality agreements clauses at CMO 14 Additional responsibilities assigned by reporting s as per time to time requirements Work Experience 8 to 10 years Education Graduation in Pharmacy Competencies



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