**Responsibilities :** - To initiate Change Control and perform impact assessment. - To perform manufacturing investigations related to deviation / OOS / OOT and market complaints to identify the root cause and implementation of appropriate CAPAs. - To ensure the compliance of quality notifications like deviations and investigations for proper closure. Review of non-conformances, deviations, change controls, internal audits, annual product quality reviews and to perform assessment on other impacting documents and related activities. - Handling of Track wise software, SAP and Documents compliance software’s. - To perform and participate in Quality risk management exercises whenever required. - To perform the gap analysis with respect to cGMP guidelines, current regulatory requirements, and SOPs, wherever required and to comply with the requirements and implement the same. - To ensure proper training to all the concerned personnel with respect to investigation outcomes. - To ensure compliance at shopfloor with respect to SOPs. - Preparation and review of Standard Operation Procedure. - Preparation and review of Standard Operation Procedure. - To perform any other task as assigned by the department manager. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com