Quality Assurance Assistant

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionAs Quality Assurance Assistant in Finished Goods Release, you share responsibility within QA Packaging, together with your colleagues, to ensure that commercial products meet specific requirements and that releases comply both with legal conformity in the customer markets and with the internal Pharma Quality Standard (PQS) requirements. You support the interface areas in all matters of GMP Compliance.The OpportunityControl of the finished packaged reference and retention samples of the products within the area of responsibility, including documentation in MES as well as sample handling and control of complaint samples.Support of the Complaint Lead Investigator in the processing of complaints and claims as well as in the execution of quality problems.Support of the QA Managers in the preparation of product releases, creation of presentations, performance of evaluations and trendings, as well as processing and review of risk assessments.Creation, revision, review and approval of GMP documents, such as SOPs, as well as filing, management and archiving of documents and retention samples.Support of inspection management during audits and inspections, including cooperation in the back office, and the provision and shipment of samples and documents for the EU-Release.Review of cleaning documentation (Cleaning Records) and control of the alarm logs of the Solids-DP production, as well as cooperation in the certification system and creation of manual certificates.Performance of cross-departmental activities to support quality assurance.Who You AreAs a QA Assistant, you ideally have several years of professional experience in pharmaceutical production, development or quality assurance, preferably in the area of manufacturing and/or packaging. You have a successfully completed training in the field of Technical Assistance (CTA/PTA) or as a laboratory technician. Alternatively, you have a corresponding vocational training combined with several years of professional experience in the GMP area.You are a positively thinking, integral and self-reflective personality with strong team skills and bring an open and quality-oriented attitude and mindset, which is required for successful work in your team and cross-departmentally. Your solution-oriented basic attitude and can-do attitude determines your daily actions.Quick comprehension and great interest in technical processes as well as affinity in dealing with IT systems as well as routine handling of IT systems (e.g. Google applications as well as relevant GMP systems)Great willingness and curiosity to develop flexibly and to learn cross-departmentally in the sense of polyvalence. This includes an interest in grasping, getting to know and improving upstream and downstream process steps; knowledge and committed use regarding process improvements (e.g. Lean Production System) as well as Agile Management are an advantage.Ability and openness to recognize and live the opportunities and advantages of changes. In this sense, an interest in the areas of coaching and change management is an advantage, as well as strong communication skills. Very good communication skills in spoken and written German, ideally also in English.Apply now with your current CV and relevant certificates and become part of our team to shape the future together! Who we areA healthier future drives us to innovate. Together, more than 100-000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let-s build a healthier future, together.Roche is an Equal Opportunity Employer.