Executive Production

Followings will be the responsibilities of the position holder: 1. Will be responsible for installation and commissioning of the new granulation equipment’s. Plan & Execute the trial of the granulation equipment’s with other CFTs and evaluate the results. 2. Responsible for appropriate qualification and validations (Equipment, Process and Utilities) are carried out in granulation area. Co-ordination with other support function for effective implementation of action item identified. 3. Handling of change control and preparation of required documents for change control. Impart training to operators & workman of granulation area on shop floor for GxP activities. New SOP preparation, review and gap identification as per guideline and Abbott Quality system requirements. 4. Work distribution and optimum utilization of manpower, To monitor the issuance of BMR Alarm Identification & management as per SOP. 5. 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 granulation area. 6. To check/review/verify operation of isolator & granulation machines as per respective equipment Operation SOP. 7. To identify the problems with the machine and undertake trouble shooting activity where required, To ensure work is carried on in the granulation department according to the SOPs. To coordinate with departmental colleagues & HOD & QA in cases of discrepancies in Granulation area. 8. Ensure compliance of all procedures, practices, and system to cGMP with respect to WHO guidelines, Abbott Quality guidelines, other applicable regulatory guidelines and Standard Operating procedures at site. Ensure that Good Documentation practices shall be comply during production process. 9. 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. 10. Responsible for investigation of exception / non-compliance in the production area, preparation and review of investigation report. Review of standard operating procedure, master documents of production and batch documents, etc