QA Associate

Job Summary:

This position shall be responsible for Oversight and Monitoring of cGMP compliance as per Sun Pharma Quality Standards for Quality Control Laboratory at Drug Substance Manufacturing site.   

Essential Job Functions:

• To ensure compliance and ATR in Quality Control Lab.


• To provide support in identification of RCA and CAPA.


• To ensure implementation and effectiveness of CAPA.


• Randomly review of analytical reports for compliance point of view.


• Reviewing OOS, OOT, Lab event, and deviation investigation related to QC.


• Preparation of OOS, OOT and Lab event trend.


• Lab Compliance (Procedural compliance verification, Lab round and verification of online QC activities).


• Proactively assess quality issues at site and ensure compliance to the defined procedures and regulatory requirements in Quality Control laboratory at site.


• Ensure that the Labs meet the requirements of GLP at all times, the quality systems are maintained, equipment are routinely checked and results recorded of correct function, etc.


• Ensure consistency QC lab operations and drive continuous improvements in laboratory performance.


• Ensure compliance to cGMP/cGLP and applicable safety standards in QC Labs.


• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.


• Preparation and Review of Standard Operating Procedure as per EDMS application.


• To perform the activity as per the user roles defined in the electronic software. (EDMS, LIMS and Track wise system).