Junior Officer

1. Comply with all cGMP, GxP, or any other regulatory requirements, including EH&S requirements.

2.     Complete  training  on  relevant  SOPs  and  develop  an  understanding  of  the  activities  to  be conducted prior to undertaking any task.

3. Conduct all tasks/ activities as per the applicable SOPs.  Report any difficulty or deviation in following the procedures/instructions to immediate Supervisor/Managers.

4. Report any quality concerns or suggestions for improvements to Supervisors/ Managers.

5. Responsible to complete the assigned trainings, applicable for workgroup “QA - Annual Product Quality Review- and Document management GOA”  in the L2LMS (SABA).

6. Data compilation And Statistical trending for Annual Product Quality Review.

 9.   To coordinate with technical training as a “Departmental Training Coordinator” to meet  required  training compliance of the department.

10.   Maintenance of stability chamber in co-ordination with engineering department, and review of temperature data.

11. To place stability samples in the chambers as per stability protocol at various intervals as per procedure specified in the SOP.

12.  Timely pullout of samples as per monthly schedule from the stability chambers and to update relevant logbooks, software for login and pull out of stability samples.

13.  Maintenance, reconciliation and withdrawal of stability samples charged in stability chamber.

14.   Handling of EDMS activities as per SOP SOP_MUM_CQA_000001, Preparation, Review, Approval, and control of Standard Operating Procedures Through Electronic Document Management Systems (EDMS).

15.  To take out Master Print of Batch Document through SAP.

16.   To take out Master print of Batch Document through PAS-X.

17.   Change Proposal, Deviation, CAPA initiation and action plan execution and closure in QAMS.

18. Comply with all EHS responsibilities as follows:

To comply current EHS Management Systems of Site.

To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements and Applicable 

 Legal Compliances.

To carry out all assigned jobs in Safe Manner.

Ensure controls effectively on High Risk Activities / Significant Environmental Aspect & Impact    Ensure continual improvement on EHS performance.