Executive - Quality Assurance

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

Requirements

• 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