Senior QA Engineer working on a range of projects for enterprise clients. Responsible for the delivery of high - quality software solutions and collaboration with engineering teams.
About the role
- QA Projekt Lead ensuring quality assurance in pharmaceuticals at Loxxess Pharma. Responsible for managing quality documentation and compliance with regulatory standards.
Responsibilities
- Support qualification and validation activities in the GDP environment
- Local document management including creation, maintenance and administration of quality documents
- Local QA contact for operational units
- Responsibility for local deviation management
- Participation in QA projects
- Preparation of quality-related documents (SOPs, qualification documentation, CAPA, Change Control) in German and English
- Contribution to the implementation of new clients at the site
- Delivery of initial and refresher training in GDP
- Responsibility for local change control processes
- Operation and monitoring of automated temperature monitoring systems
Requirements
- Completed degree in natural sciences or engineering (e.g., biosciences, pharmacy, chemistry, medical engineering, biotechnology) or an equivalent qualification
- Alternatively: completed vocational training in the pharmaceutical sector or equivalent with several years of professional experience and/or further qualification in GDP/GMP quality management
- Relevant professional experience in quality assurance (GDP or Medical Devices), ideally in pharmaceutical wholesale
- Solid knowledge of regulatory requirements in the pharmaceutical environment
- Experience in pharmaceutical quality assurance (GDP and/or GMP) is mandatory
- Fluent German (C2) and very good English (at least C1) both written and spoken
Benefits
- Personal development: We support your professional growth through training in relevant and other interesting topics
- Flexible workplace: After completion of onboarding, the option to work remotely up to two days a week
- Vacation: 30 days of annual leave per year
- Pension and protection: employer contribution to company pension scheme and company disability insurance
- Health and wellbeing: Nilo Health is a digital platform that helps companies promote the mental health of their employees. It offers practical exercises, helpful tips and targeted programs to build mental resilience and overall wellbeing
- Additional benefits: employee discounts via Corporate Benefits, bike leasing via JobRad, Wellpass and employee parking
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