Role & responsibilities
To take plant round and monitor production activities at shop floor.
To prepare appropriate Quality related documents like SOP, BMR, BCR, BPR etc.
To review BMRs, BCRs, and analysis records before release of API.
To perform sampling of API's and maintain its records.
To maintain control samples of API and its records.
To perform and ensure the cleaning of sampling tools.
To provide line clearance at the time of product changes over.
To review dispatch of finished product and maintain record for the same.
To Investigate the deviations identified in co-ordination with QA-Head/Designee.
Product quality review of API
Process and cleaning validation monitoring in plant