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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