Beschreibung

As a Senior QA Compliance Specialist, you will dive into complaint investigations, ensuring quality and compliance while coordinating with various departments. This role also involves managing samples, identifying improvements, and preparing for audits, all while upholding high health and safety standards.

Anforderungen

• •Degree in natural sciences (pharmacy, chemistry, medicine, biology, microbiology)
• •Experience in manufacturing medicinal products for human use
• •Working experience in GMP production, Quality Assurance, or Quality Control
• •Good knowledge of MS Office applications and standard IT applications
• •Capability to set priorities and work under pressure
• •Ability to work well with internal and external participants
• •Fluency in English and German ideally
• •Action-oriented, compliance requirements, continued learning, dealing with ambiguity, functional skills, GMP procedures, GxP, industry standards, process optimization, QA (Quality Assurance), quality standards, self-awareness, technological expertise, technological intelligence

Aufgaben

• •Investigate technical and mixed product complaints
• •Ensure quality of investigations
• •Coordinate actions across departments to complete investigations
• •Prioritize workload to meet deadlines
• •Support approval and closure of complaints
• •Manage sample processes and related activities
• •Identify improvement opportunities and support implementation
• •Standardize complaint processes for new products
• •Assist the complaint team in preparing for audits
• •Update complaint procedures and work instructions to align with regulations

Tools & Technologien

Benefits