Location: Rail, Punjab, India - Category: Quality
Officer - 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.
- SAP key user
- 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 good housekeeping in the working area as well as in surroundings.
- 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.