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QA Complaint Coordinator (80-100%)
Job ID192966BRPosition TitleQA Complaint Coordinator (80-100%)DivisionPHARMABusiness UnitRegion Europe GenMedCountrySwitzerlandWork LocationRotkreuzCompany/Legal EntityNovartis Pharma Schweiz AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularJob DescriptionTo support management of Quality Assurance operational processes at Country Pharma Organization (CPO) in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for Complaint submission and processing of Novartis marketed products.
• Manage collection and assessment of Initial Criticality of complaints in collaboration with local DS&E, MIC.
• Opening, reporting, processing, follow-up and closing of Quality complaints reports for all released drug products (Pharma and Vaccines).
• Management and maintenance of the global AQWA Complaint database for Pharma drug products.
• Management and maintenance of the local Complaint database for Vaccines products.
• Perform reconciliation with other departments (e.g. Medical Information, DS&E and third party contractor, if applicable) for potential AEs resulting from medical inquiries and quality related complaints.
• Survey and monitor Complaint KPIs from Global QA and provide update to local CPO organization.
• Implement and maintain the local Quality System in the areas of GMP, GDP and GPvP, in accordance with the Novartis Quality Manual and the CPO Quality Plan (Quality Manual authorization and implementation).
• Release of commercial products: Support GMP QA Manager and QA Associate / Assistants in the release of all drug products to the market.
• Deputy of CPO QA Project Manager (Trainingsmanagement, AQWA Key User Role)
• Is obligated to report any Adverse Event or Technical Quality Complaint within 24h from the receipt to the DS&E Safety Desk (email@example.com) or Complaint Coordinator (firstname.lastname@example.org) in accordance to the valid local SOPs.Minimum requirements• University Degree (Master/PhD) in Pharmaceutical Science, Biology or Medicine
•Ideally a first experience in the pharmaceutical environment e.g. QA, Drug Safety, Medical Information
• Native German, fluent English (written and spoken), French conversational is a must
• Knowledge of pharmacological and medical terminology
• Excellent communications and interpersonal skills
• A strong quality and customer focused attitude