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QA GMP Associate (80-100%)
Job ID192951BRPosition TitleQA GMP Associate (80-100%)DivisionPHARMABusiness UnitRegion Europe GenMedCountrySwitzerlandWork LocationRotkreuzCompany/Legal EntityNovartis Pharma Schweiz AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularJob DescriptionResponsible for the market release of products and related activities including artwork reviews and approvals.
Supports activities for Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP).
• 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.
• Prepare and review the required documentation for the timely market release of products and related activities.
• Responsible for the release of marketed product batches and related packaging materials in close cooperation with the QA GMP Manager as delegated by the Responsible Person. Maintain the release database. Update the SAP system.
• Review relevant global and local Product Quality Reviews (PQRs).
• Review and approve artwork releases and artwork changes.
• Support and track the implementation and maintenance of the local Quality System in the areas of GMP, GDP and GPvP, in accordance with the Novartis Quality Manual and the CPO Quality Plan.
• Support in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appropriately in order to mitigate risk.
• In cooperation with the local GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces.
• Participate in QA investigation activities, as appropriate.
• Support CPO readiness for all GxP regulatory inspections and internal audits.
• Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPAs have been completed/closed.
• Ensure that computerized systems are adequately identified during the High Level Risk
• Assessment for GxP relevance to enable their validation where required.Minimum requirements• University Degree (Master or PHD) in Life Sciences or related fields.
• Ideally previous experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, clinical development or a related area.
• Good oral and written communication skills
• Knowledge of relevant local regulatory requirements
• A good understanding of GxP and ICH guidelines
• German and English fluent in speaking and writing. Knowledge of French desired.