Quality Assurance Intern

Job description

Job Description

The purpose of the QA Specialist role is to support QA Managers for the Quality Oversight of BTDM ESO DP 3rd party manufacturers for production, batch review and release, Product Quality Reviews, changes, deviations and CAPA's, complaints, overdue tracking and performance of quality systems assessments. This role requires knowledge of and adherence to specific cGMP requirements and execution according to the valid SOP's.

• Support all activities related to Quality Oversight within ESO QA Biologics DP. Ensur-ing compliance according to the NTO internal quality standards, relevant regulatory requirements and the filed product quality standards.
• Initiate and support review of deviations from third parties in alignment with the respective Quality Assurance Manager. Support the Quality Assurance Manager for review of complaints related to the products manufactured at the respective Third Parties. Work together with Third Parties to ensure that adequate information required for a timely investigation at a Third Party is provided. Complete investigations for minor and major recurring complaint cases with standard answer as directed.
• Ensure that Change Requests, either from the External Supplier or from ESO QA Biolog-ics DP, are managed according to the Quality Agreement and Novartis SOPs from re-ceipt, through to implementation and closure. Work together with Third Parties and in-ternal partners within Novartis to ensure that adequate information required for a time-ly execution at Third Party is provided.
• Support Batch Record Review of Drug Product manufacturing production records. Pre-pare final documentation for batch release including confirmation of batch status and quantities within SAP systems.
• Prepare the APR/PQR content for review and assessment by the respective QAM and Technical representative.
• Perform weekly and monthly tracking related to complaints, deviations and actions within ESO QA Biologics DP, including reporting of overdue items and trending. Work together with QAMs and QA Leads to ensure compliance of process.
• Assess QA Agreements to ensure alignment of required Novartis global templates.
• Support Self- inspections.
• Contribute to the maintenance and creation of SOPs

Desired profile

Minimum requirements

• Bachelor of a scientific-technical course or technical course or students who are currently doing their Masters. Recent Bachelor/Master Postgraduates (graduation not longer than 6 months ago) will be considered as well.
• Fluent in German and English.
• Experience in the pharmaceutical industry or in the GMP environment would be of advantage.