**Following will be the responsibilities of the position holder :** + To develop, ensure, implement and maintain a GxP compliant Laboratory systems. + To ensure training and effective implementation of current Good Laboratory Practices. + To establish and ensure analysis, approval / rejection of starting materials, packaging materials, intermediate, bulk & finished products as per validated Pharmacopoeia / In — house method for Oral Dosages and LVP facility. + To ensure that the appropriate validations, including analytical procedures, and calibrations of equipment are done. + To Ensure the Maintenance of the Department, Premises and Equipment. + To ensure all necessary testing and stability studies are carried out for Oral Dosages and LVP facility as per the approved specifications and applicable guidelines. + To ensure that the specifications and the testing methods are in line with the latest guidelines and applicable pharmacopoeias + To approve specifications, sampling instructions, test methods & other Quality control procedures for oral and liquid injectable facility. + To approve and monitor all contract analysis. + To Ensure the required initial and continuing training of Quality Control personnel is carried out and adapted as per requirement. + To assist in the investigations related to the laboratory, product failure, incidents and Risk assessments. + Review and disposition of the non-conforming materials in co-ordination with Quality Assurance. + To ensure the compliance of the Quality Management System and CAPA effectiveness related to the Laboratory. + To apply total quality management tools and approaches to analytical and reporting processes. + Create and direct environmental monitoring programs in line with the regulatory requirements. + To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements and making recommendation for improvement as appropriate. + To monitor and report quality control progress, notify any discrepancies or potential concerns to the site Quality Head. + Support the development of quality goals and targets as part of the organization’s strategic plan. + Maintain active role on internal continuous improvement initiatives. + To Design, develop and implement quality control training programs. + To ensure the self-training in the ISO train within the stipulated time frame. + Business Administrator for Darius System, to ensure the review and approval of documents in Darius. + To be responsible for Laboratory Quality management system and internal Audit as per NABL ISO/IEC 17025. + In absence of the position holder, the Manager/ Group manager working in the respective section or shall be responsible for day to day working. **Minimum Education** **M.Sc / B.Pharm / M.Pharm / Ph.D in pharmacy having relevant experience of around 15+ years in quality control functions in a formulation plant. Should have faced and managed regulatory audits such as USFDA / EU GMP independently** 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