Followings will be the Core Job Responsibilities of the position holder:
1. Compliance of current Good Manufacturing Practices in the Hormone Facility to follow GDP with data-integrity compliance. 2. Responsible for installation and commissioning of the new manufacturing equipment s. Plan execute the trial of the manufacturing equipment s with other CFTs and evaluate the result. 3. Responsible for appropriate qualification and validations (Equipment, Process and utilities) are carried out in the manufacturing area. Co-ordination with other support function for the effective implementation of action item identified. 4. To handle various transaction in SAP. 5. Responsible for achieving monthly target of production department. 6. Handling of QMS documents, impart training to subordinates in manufacturing area on shop floor for GxP activities. 7. Work distribution and optimum utilization of manpower. Alarm Identification and management as per SOP. 8. To ensure all in-process checks and monitoring of all intermediate processes, to check set process parameters in PLC/SCADA as per BMR before machine run in manufacturing area. 9. Ensure compliance of all procedure, practices and system to cGMP with respect to Abbott Quality guideline, other applicable regulatory guidelines and standard operating procedures at site. Ensure that Good Documentation Practices shall comply during the production process. 10. To check/ review/verify operation of manufacturing machine as per respective equipment operation SOP. 11. Provide input and guidance to improve the right first time of the production batch/ batch documents. Preparation, review of protocol and report (Technical/ Study/ Non-routine) on need basis. 12. To identify the problems with the machine and undertake trouble shooting activity where required, upkeep the change parts, to ensure work is carried in the Manufacturing section according to the SOPs, to coordinate with departmental colleagues, HOD QA in cases of any discrepancies in manufacturing Section. 13. Responsible for investigation of exception/ non-compliance in the manufacturing area, preparation and review of investigation report. Review of standard operating procedure, master documents of production and batch document etc. 14. Preparation, review and execution of commercial batch, PV protocol/ BMR. 15. Dispensing and manufacturing process compliance in accordance with approved BMR. 16. To carry out line clearance, In-Process checks at the different stages of manufacturing. 17. SOP training in ISOtrain of self-train within stipulated times and to ensure no past due training. 18. SOP preparation and upload in Darius as per need. 19. To follow all the practices related to safety and COBC. 20. To support the team on additional responsibilities assigned time to time. In absence of the position holder, the sub-ordinate Executive / Manager working in the section, or the authorized designee (as applicable) shall be responsible for day to day working.
