Executive - Quality Assurance

About this role

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.