Veterinarian, pharmacist, chemist or chemical engineer with appropriate experience in pharmaceutical industry (veterinary/human) with focus on quality and / or production activities
Qualification as responsible pharmacist / authorized person according to local requirements, if applicable
Strong pharmaceutical and regulatory background (GMP / GDP Compliance)
Excellent communication and negotiation skills
Organizational and administrative skills
Very good written and spoken English skills
Experience in training
Job Description
The employment time will be limited. The position "Animal Health Country Quality Representative" is limited for 24 months
Responsible for the oversight of local quality processes (e.g. GMP/GDP) and their implementation within the country organization, especially for: Transportation and warehousing activities, 3rd party business (e.g. local contract manufacturing activities, repackaging / relabeling), incl. quality assurance agreements (QAAs), local change management, technical complaint handling & Quality related issue management incl. deviation management, Market Release (if applicable according to local requirements)
Establishes and maintains local Quality Management System (in line with internal and external regulations)
Represents Quality in Senior Management of the country organization (e.g. QMR) and has interlinkage to local functions performing Quality (e.g. GDP/GMP) relevant processes (e.g. SCM)
Acts as primary contact to agencies regarding quality related issues and provides local support for Health Authority Inspections
Ensures quality training (e.g. GMP /GDP) for the local organisation
Ensures smooth transition of the Animal Health Country Quality function from Bayer Legal Entity to New Elanco Legal Entity