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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 Elanco’s 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
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