Job Description:

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Key Responsibilities:

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Documentation Management:

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Review, approve, and control various quality documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Specifications, Test Procedures (STPs), and other quality-related documentation.

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Ensure proper archiving, retrieval, and revision control of all controlled documents.

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Participate in the preparation and review of site master files (SMF), validation master plans (VMP), and annual product quality reviews (APQR).

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In-Process Quality Assurance (IPQA):

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Conduct regular in-process checks and online monitoring of manufacturing operations to ensure adherence to BMRs, SOPs, and cGMP guidelines.

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Perform line clearances before starting recent batches and product changeovers.

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Verify dispensing of raw materials and ensure proper handling and storage of materials throughout the production process.

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Monitor environmental conditions (temperature, humidity, etc.) in manufacturing and storage areas.

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Collect and control in-process,



intermediate, semi-finished, and finished product samples.

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Batch Release Activities:

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Review executed BMRs, BPRs, analytical records, and other relevant documentation for completeness, accuracy, and compliance with specifications and cGMP.

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Ensure all deviations, incidents, OOS/OOT results, and change controls related to a batch are properly investigated, documented, and closed before batch release.

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Prepare and/or review batch release documentation for final product disposition.

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Quality Management Systems (QMS):

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Actively participate in the implementation and maintenance of the Quality Management System (QMS).

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Initiate, investigate, and close deviations, incidents, Out-of-Specification (OOS), and Out-of-Trend (OOT) results, ensuring root cause analysis and effective CAPA (Corrective and Preventive Actions) implementation.

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Review and approve change control requests, ensuring proper

📌 Chemist / Officer / Executive / Assistant Manager - Quality Assurance (Ankleshwar)
🏢 SDP HR Solution
📍 Ankleshwar