**Qualification : B Pharm/ M. Pharm** **Experience : 15 to 20 years.** **J** **ob Responsibilities** + Ensure compliance of all procedures, practices and system to cGMP with respect to Schedule M., WHO guidelines, Abbott Quality guideline and Standard operating procedures at site. + Responsible for QMS. + To review and approve the investigation reports of Exception and market complaint. + To review and approve the change control, planned deviation in track wise. + To review and approve the site complaint investigation and accountable for timely closure of site complaints. + To review the CAPA and track its implementation within the timeframe. To check the effectiveness of CAPA implemented. + To monitor the site internal audit program and its compliance. Participation as an Auditor in internal audit. + To ensure implementation of EQD Policies on site within the given timeframe. + Management of Document issuance and archival. + To review and approve site SOP, specification documents in DARIUS. + Review of product quality review, evaluation of product trends. + To ensure implementation of site training management activities. + Management of control sample activities. + Monitoring of Batch records preparation and review of master batch records. + Handling and management of QRM program at site. + Management of Supplier Complaint and Service Providers. + To deliver the training at site on GMP topics, SOPs and other technical topics. 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