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Consultant - Quality Assurance
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Full-time
- Responsibilities: Assure the robust selection and on-boarding of CMO’s / Suppliers that perform testing for Elanco are in compliance with regulatory cGMP requirements and the Elanco Quality Manual / DirectivesManage and support the resolution of issues at CMOs/Suppliers, escalate issues appropriately and timely drive corresponding continuous improvement initiatives.
- Manage contract laboratories that perform testing of commercial productsReview and approve OOS, OOT Investigations, and deviations related to QC activities and perform assessments and visits of contract manufacturers and laboratories.
- Collaborate and/or partner with Global QC network, QA/QC and TS/MS SMEs across organization in projects and routine to support multi-countries marketed products.
- Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or trainingComply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
- What You Need to Succeed: (basic qualifications):Degree in chemistry, biochemistry, engineering, pharmacy, biologyMinimum 8 years demonstrated Quality/technical leadership experience in the pharmaceutical industry, specifically supporting method transfers, method validation, method optimization, compliance remediation activity.
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