Lead CAPA and QA activities in a GMP-regulated environment.
Drive continuous improvement of the quality system, training and compliance to protect product quality and patient safety.
Responsibilities
In a GMP-regulated environment, ensure compliance with all quality, GMP and regulatory requirements throughout manufacturing, testing and shipping.
Manage deviations and CAPA from root cause analysis through SAP-based implementation to effectiveness checks and final evaluation—working together with process owners.
Further develop the quality management framework by creating, maintaining and delivering company-wide training on overarching procedures and processes.
Increase awareness and compliance within teams through internal trainings on quality-relevant topics.
Review manufacturing documentation for GMP compliance, derive corrective actions and track their implementation.
Act as a sparring partner for the operational departments by supporting the development of GMP-compliant procedures and promoting stable process flows.
Drive QA projects forward and take project leadership when required; confidently represent supported quality processes during inspections.
Maintain focus on product impact and patient safety by conducting thorough investigations and producing well-founded risk assessments.
Requirements
Completed bachelor’s degree in a natural science, ideally with a focus on quality management
Qualification as a quality representative or equivalent professional experience desirable
At least 5 years’ professional experience in quality management in the medical device or pharmaceutical sector, or in project management within these industries
Solid knowledge of relevant regulatory requirements: GMP, GDP, ISO 13485, FDA Quality System Regulation, MDR
Good command of English, both written and spoken
Fluent in German, both written and spoken
Benefits
Exciting responsibilities — work with a high degree of ownership in an ambitious environment with excellent development opportunities
Attractive compensation — competitive base salary according to the chemical industry collective agreement, annual one-off payments (holiday pay, 13th salary, future contribution) and expansion of statutory long-term care insurance with a supplementary care policy
Financial additional benefits — support for private retirement provision, a life-phase account for paid leave (e.g., sabbatical, early retirement), discounts in numerous (online) shops, and bicycle leasing
Structured working hours — 37.5 hours per week, 1–2 days of remote work per week, time off in lieu for overtime, age-related leave schemes, 30 days annual leave, and special leave for exceptional occasions
Health & well-being — occupational health service with comprehensive preventive examinations, social counseling and an on-site employee canteen with freshly prepared meals daily
Sustainability and social engagement — sustainability as part of the company strategy and targeted support for initiatives in education, family and science through the company’s own foundations
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