Jubilant Bhartia Group

Long Description

Key Responsibilities.

1. Shall be responsible for quality oversight in Production blocks and shall review process, procedure, facility and training.
2. Batch release (or reject) activity for API’s manufactured at all Plants. This includes review of BPRs, review of IOCBN, verification and distribution of PAF, review of product label and approved label, retaining control sample and verification, inspection as per the checklist for finished product release to customers and updating of finished product distribution records.
3. Review & evaluation of change controls, clean room allocation form, material re-allocation form, reprocess approval form and Packing clearance form and closure of the same before the product release.
4. Responsible for visual inspection and line clearance for the product change over activities.
5. Perform the cleaning validation samples as per approved protocol.
6. Must have knowledge on handling all QMS related activities.

Long Description

1. Shall be responsible to identify the area of improvement and to review the followings:

• To review training records on the particular operations that the employee performs.
• Plant area & pharma room cleaning is performed as per established procedure.
• Equipment status board are updated with current status.
• Availability of current version of SOP for operation and calibration of equipment in the work
• Place & accessible to operating personnel.
• Batch production records are placed in work stations during the entire operations.
• Equipment usage and cleaning log is updated by operating personnel.
• Sampling procedure for in-process & intermediate is followed by operating personnel.
• Weighing balance/measuring instruments used in production are calibrated as per established procedure and records are maintained.
• All the accessories (scoops, samplers, scrapper etc.) are coded and cleaned as per established procedure.
• Online monitoring the recording of batch production record & batch cleaning record to comply the ALCOA.
• Dispensing of intermediates and cleaning of dispensing room performed as per established procedure.
• Intermediates, rejected materials are stored in designated place and temperature & relative humidity is maintained.
• Entry & exit procedure available in the clean room & followed by operating personnel during routine operations.
• Equipment are cleaned within the specified time after use as per established procedure.
• Sampling procedure for cleaning samples during product changeover cleaning is followed by operating personnel.
• Monitoring of process & cleaning validations executing as per approved protocol.
• To coordinate for root cause investigation for product failures & customer complaints.
• Coordination and implementation of CAPA for all audit observations & any non-conformances.
• Communicate with management, production regarding questionable measurements, non-conformance issues.
• Shall be responsible for SAP activities.
• Shall be responsible for lifecycle management activities of production
• Shall be responsible for the track wise activities. 
• Shall be responsible for initiation & evaluation of CCF, MRF, PCF, CRF & RPF in track wise and SAP.

Long Description

Long Description

Skills