Description

In this role, you will focus on ensuring product quality by creating specifications, conducting supplier qualifications, and managing quality assurance agreements. Your day-to-day responsibilities will involve reviewing documentation, handling deviations, and supporting audits, all aimed at maintaining high standards throughout the product lifecycle.

Requirements

• •Completed scientific degree in chemistry, pharmacy, or biology, preferably with a doctorate
• •Solid knowledge of ISO 13485 and additional regulations in quality and risk management and pharmacy
• •Leadership experience
• •Experience in project management and knowledge of Lean Quality and quality tools
• •Knowledge of production processes and facilities for medical technology or pharmaceutical products under GMP conditions, preferably in the polymer field
• •Knowledge of supplier management and auditing experience
• •Excellent verbal and written communication skills in German and English
• •Strong analytical skills, high problem-solving competence, and strong team orientation

Tasks

• •Create GMP specifications for raw materials and finished products
• •Support the preparation of technical finished product specifications
• •Conduct supplier qualifications and qualify external service providers as needed
• •Create and track quality assurance agreements with contract manufacturers
• •Create and track change control requests
• •Support process validation activities
• •Review manufacturing instructions and validation documents during method validation
• •Prepare quality reviews for products, raw materials, media, and equipment
• •Handle deviations, complaints, and CAPA during product introduction
• •Provide audit support and manage audits when necessary

Benefits