Job Description

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals\' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco\'s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being. Position Description: As the Manager Quality Assurance for the Elanco external manufacturing (EEM), the responsibility is providing quality oversight of assigned contract manufacturer organizations (CMOs) and suppliers within Elanco\'s network in India/Bangladesh. The primary responsibility of this position is to ensure the third-party manufacturer (CMOs) are effective and complaint with relevant regulations and internal requirement, thereby ensuring products released to market are fit for intended purpose and meet all legal and internal requirements. As Manager QA, you need to drive and maintain improvements in the quality systems and processes, at CMOs and suppliers, and to provide advice on all quality and compliance matters to ensure compliance at all levels. Functions, Duties, Tasks: Ensure that all marketed products are dispositioned in accordance with local regulations and internal requirement. Technical understanding of manufacturing/testing & product release processes Support and provide Quality input for qualification and validation activities at Third Parties and product launches. Manage and support change control/deviation activities at Elanco and with Third Parties. Evaluate Third Parties Product Quality Reviews to pro-actively analyse and monitor quality trends on supplier level including the implementation of necessary corrective actions. Schedule and follow up on audits at Third Parties and Suppliers and monitor the corresponding corrective actions, in line with the Elanco Global Compliance and Auditing team requirements/timelines. Implement continuous improvement initiatives associated with quality systems to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance. Implement quality management review and governance processes to ensure they are efficient and compliant. Collaborate with regional quality network to identify and implement global processes and report local quality metrics. Drive the utilization of Risk Management principles for Third Party oversight. Participate as QA function in Elanco\'s launch project to ensure the timely launch of new products Manage all assigned QA related projects and analytical method transfers and validations in collaboration with internal and external (CMOs) coordination. Evaluate and support the remediation of any quality related issue and non-conformity at CMOs and drive continuous improvement initiatives. Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies. Support Regulatory submissions. Attributes : Excellent verbal, written, and interpersonal communication skills. Strong attention to detail with a focus on laboratory practice and documentation skills. Preference will be towards a candidate with experience in manufacturing support. Demonstrated problem solving, quality risk management and decision-making skills Excellent interpersonal and communication (written and oral) skills Mobile - able to travel Experience: About 10 to 15 years of experience with at least 5 years exposure in in shop floor manufacturing plant at QA/QC function, who has lead the team of 5 or more people in supervisory level At least 3 to 4 years recent working experience in contract manufacturing for formulation industries Preferred if having 3 to 5 years\' experience on QC lab, analytical testing, exposure in method validation, and review of QC data Exposure in working of regulated market preferred Exposure to regulatory audits preferred Qualifications: Msc. B.Pharma 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

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