Sr. Executive

5 days ago

Navi Mumbai, Maharashtra, India Lupin Full time ₹ 6,00,000 - ₹ 18,00,000 per year
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 Competencies

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