Assistant Manager Qa

At Elanco NYSE ELAN it all starts with animals As a global leader in animal health we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets Were driven by our vision of xe2x80x98Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purposexe2x84xa2 to advance the health of animals people the planet and our enterprise At Elanco we pride ourselves on fostering a diverse and inclusive work environment We believe that diversity is the driving force behind innovation creativity and overall business success Here youll be part of a company that values and champions new ways of thinking work with dynamic individuals and acquire new skills and experiences that will propel your career to new heights Making animals lives better makes life better join our team today As the Assistant Manager Quality Assurance for the Elanco external manufacturing EEM the responsibility is providing quality oversight of assigned contract manufacturing organizations CMOs and suppliers within Elancos network in India The primary responsibility of this position is to ensure the CMOs are compliant with relevant regulations and Elanco requirement thereby ensuring products released to market are fit for intended use and meet all legal and Elanco requirements As Assistant Manager QA you need to drive and maintain improvements in the quality systems and processes at CMOs suppliers and to provide advice on all quality and compliance matters Responsibilities Duties Tasks Ensure that all marketed products are dispositioned in accordance with local regulations and Elanco requirements Drive the utilization of Quality Risk Management principles for contract manufacturing sites Ensure Quality activities of pharmaceutical products at identified CMOs to comply with the requirements of the Elanco Global standards and meet all relevant cGMP regulatory requirements Manage and support change control deviation non-conformance and market complaint investigation at Elanco and contract manufacturing sites Manage Quality agreements with contract manufacturing site Support and provide quality input for Qualification and validation activities at CMOs and product launches Management of Product Quality Reviews PQR of CMOs- Review of PQR corrections follow-up actions monitoring of PQR trends Schedule and follow up on audits at contract manufacturing sites and suppliers and monitor the corresponding corrective actions in line with Elanco Global Compliance and Auditing team requirements timelines Implement continuous improvement initiatives quality management review and governance associated with quality system to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance Review of analytical data chromatograms specifications and method of analysis Manage QA related projects including analytical method transfers and validations in collaboration with cross functional team Manage stability program of products manufactured to ensure that products meet the specification up to its recommended shelf life Comply with all company local and global policies including Quality frameworks code of conduct anti-discrimination harassment and health safety and environment HSE policies Basic Requirements Education M Pharma B Pharma M Sc Experience Minimum 6 to 8 years of experience with exposure in shop floor manufacturing QC laboratory who has led the team of 2 or more people in supervisory level Candidates with analytical QC background with experience in handling HPLC GC AMV and Stability shall be preferred Exposure of SAP and Quality Management System software will add advantage Exposure of working in a regulated market with audit exposure shall be preferred Exposure to packaging material will be added advantage Elanco is an EEO Affirmative Action Employer and does not discriminate on the basis of age race color religion gender sexual orientation gender identity gender expression national origin protected veteran status disability or any other legally protected status