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: To participate in vendor qualification activities. To participate in Internal/External audit activities To ensure compliance as per applicable regulatory requirement. Release/rejection of finished products, intermediates & raw material as per approval specification Creation & release of Certificate of analysis. Issuance and review of Batch production records. QC analytical data review. Handling sales return, recalls and compilation of APR data To coordinate investigation of market complaints/deviation/OOS/OOT. Log books management for various activities. To ensure that sampling of all Finished products are done as per defined procedure and proper record is being kept compliance to cGMP practice. To ensure compliance to all SHE guidelines and to ensure safe working. Conducting monthly safety audit and ensuring the closures of observations. Reporting of Near misses/Incidents. Ensuring that all SHE related guidelines/rules are followed while doing any activity to achieve the goal of SAFE place to work. Clearance of safety work permits to ensure execution of activities in safe manner. To release the Batches of Intermediates and Finish goods in SAP.
- 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.