- 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
Executive - Quality Assurance - Rupnagar, India - Centrient Pharmaceuticals
Centrient Pharmaceuticals
Rupnagar, India
Found in: Talent IN 2A C2 - 4 hours ago
Description
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: