Quality Control department functions for assuring the quality of all the batches manufactured,
at every stage of manufacturing/processing excipients and drug products.
Sampling, inspection & testing as per specifications of Raw material for release or rejection
& its documentation.
Sampling, inspection & testing as per specifications of packaging material for release or
rejection & its documentation.
Sampling, inspection & testing as per specifications of in-process product for release or
rejection for further processing or reprocessing & its documentation.
Sampling, inspection & testing as per specifications of finished products for release or
rejection for further processing or re-processing & its documentation.
Release or rejection of every batch of Drug Products for distribution and sale.
Stability chamber handling, Stability testing and evaluation of shelf-life of products as per
the stability interval planner.
To prepare or review of stability testing protocol and report and summary report.
Microbiological analysis of raw material,
finished products, water and environmental bio-
burden monitoring.
To review of monthly trend prepared for physicochemical and microbiological trend data
and it’s complying with the predefined specifications.
Analytical investigation for complaints and product recalls.
Analytical support for evaluating the Change Control proposals & Systems.
Out of specification investigations for laboratory results.
Investigation of deviations in the analysis.
Analysis of Returned products (salvage and disposal).
Internal Quality System Audits and Quality Review.
Analysis for Control of non-conforming products.
Reference standards, working standards, solution preparations.
To plan and manage all the activities of the Quality Control Department To assure the
quality of all products manufactured by the Company.
To co-ordinate with manufacturing department in controlling their process and produ
📌 General Manager Ankleshwar
🏢 SDP HR Solution
📍 Ankleshwar
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