Executive Production | Abbott | Baddi

Job Description

Followings will be the responsibilities of the position holder:

• Will be responsible for the installation and commissioning of the new granulation equipment. Plan & Execute the trial of the granulation equipment with other CFTs and evaluate the results.
• Responsible for appropriate qualification and validations (Equipment, Process, and Utilities) carried out in the granulation area.
• Coordination with other support functions for effective implementation of action item identified.
• Handling of change control and preparation of required documents for change control. Impart training to operators & workmen of granulation area on the shop floor for GxP activities. New SOP preparation, review, and gap identification as per guidelines and Abbott Quality system requirements.
• Work distribution and optimum utilization of manpower, To monitor the issuance of BMR Alarm Identification & management as per SOP.
• 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.
• To check/review/verify the operation of isolator & granulation machines as per respective equipment Operation SOP.
• To identify the problems with the machine and undertake troubleshooting activity where required, To ensure work is carried on in the granulation department according to the SOPs.
• Coordinate with departmental colleagues & HOD & QA in cases of discrepancies in the Granulation area.
• Ensure compliance of all procedures, practices, and systems to cGMP with respect to WHO guidelines, Abbott Quality guidelines, other applicable regulatory guidelines, and Standard Operating procedures at the site.
• Ensure that Good Documentation practices shall comply during the production process.
• Provide input and guidance to improve the right first time of the production batch/batch documents. Preparation, and review of protocol and report (Technical / Study / Non-routine ) on a need basis.
• Responsible for investigation of exception / non-compliance in the production area, preparation, and review of the investigation report. Review of standard operating procedure, master documents of production and batch documents, etc.

Experience & Qualifications:

Experience Required:

• B.Pharm / M.Pharm with 6-7 years of experience in the core Production area.
• Approved chemist license & Exposure to Isolator, GEA blender candidate shall be preferred.
• Should have expertise in negative isolators & in the granulation department & Shall also have compression experience.
• Should have exposure to machine installation & qualification activity.
• Well-versed with CAPA, and GMP Documentation
• Should have exposure to regulatory audits such as MHRA, USFDA, etc.