Review of Batch Production Records
Handling of critical deviations & Investigation initiative.
Handling quality complaints are investigated and appropriate corrective and preventive actions are taken.
Handling investigations & closing of OOS results.
Follow-up & verification for the effectiveness of corrective actions /preventive actions that are implemented consequent to deviations, quality complaints, OOS results, internal audits, external audits and product reviews.
Compilation & handling of Annual product reviews..
Strong Knowledge in process validation, Equipment Qualification, Cleaning validation, and other GMP related activities/systems.
Document control with regard to issuance, revision, superseding and withdrawal of obsolete documents.
Good Knowledge in QMS & EMS.
Reporting to the Head QA