To ensure that the Products provided to the market are tested as per Customer specifications and in compliance with applicable pharmacopoeias as well cGMP/GLP/ICH/USFDA /ISO guidelines.
Key Responsibilities:
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To participate in vendor qualification activities.
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To participate in Internal/External audit activities
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To ensure compliance as per applicable regulatory requirement.
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Release/rejection of finished products, intermediates & raw material as per approval specification
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Creation & release of Certificate of analysis.
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Issuance and review of Batch production records.
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QC analytical data review.
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Handling sales return, recalls and compilation of APR data
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To coordinate investigation of market complaints/deviation/OOS/OOT.
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Log books management for various activities.
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To ensure that sampling of all Finished products are done as per defined procedure and proper record is being kept compliance to cGMP practice.
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To ensure compliance to all SHE guidelines and to ensure safe working.
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Conducting monthly safety audit and ensuring the closures of observations.
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Reporting of Near misses/Incidents.
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Ensuring that all SHE related guidelines/rules are followed while doing any activity to achieve the goal of SAFE place to work.
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Clearance of safety work permits to ensure execution of activities in safe manner.
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To release the Batches of Intermediates and Finish goods in SAP.
Requirements
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Post-Graduation in Chemistry having knowledge of cGMP & GLP guidelines, ICH/ USFDA guidelines.
- Knowledge of documentation related to quality and regulatory guidelines.
- Minimum 9 years of experience in Pharmaceutical industry and extensive Quality Assurance experience in API manufacturing industry.
