About this role
Job Description
- Comply with all cGMP, GxP, or any other regulatory requirements, including EH&S requirements.
- Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task.
- Conduct all tasks/ activities as per the applicable SOPs.
- Report any difficulty or deviation in following the procedures/instructions to immediate Supervisor/Managers.
- Report any quality concerns or suggestions for improvements to Supervisors/ Managers.
- Responsible to complete the assigned trainings, applicable for workgroup “QA - Annual Product Quality Review- and Document management GOA” in the L2LMS (SABA).
- 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.
- Work Experience 1 Year Education Graduation in Pharmacy Competencies