Complaint Lead Investigator(m/w/x)

Description

You will ensure pharmaceutical safety by leading complaint investigations and root cause analyses, collaborating across the organization to develop corrective actions and maintain GMP compliance.

Requirements

• •Responsibility, determination, and result-oriented mindset
• •Ability to build trusting relationships
• •Understanding of quality and compliance fundamentals
• •Very good organizational skills
• •Strategic thinking and planning skills
• •Ability to maintain inspection readiness
• •Degree in Pharmacy, Microbiology, Chemistry, Biochemistry, Device Engineering or equivalent
• •Ideally 2 years pharmaceutical industry experience
• •Experience in a GMP-regulated environment
• •Expert knowledge of pharmaceutical quality systems
• •Expert knowledge of pharmaceutical cGMP regulations
• •Cross-functional collaboration and investigation management skills
• •Business-fluent English and German skills

Tasks

• •Coordinate and process external complaints independently
• •Follow current GMP rules and regulatory requirements
• •Document investigations accurately and completely
• •Create and evaluate trend analyses
• •Identify potential quality problems through data
• •Escalate critical complaints to leadership and stakeholders
• •Participate actively in root cause analyses
• •Present critical complaints at QRB and GEG
• •Collaborate on-site to develop cross-functional solutions
• •Define action plans and corrective measures
• •Prioritize tasks to meet deadlines and goals
• •Manage competing priorities through effective escalation
• •Present complaint investigations during audits and inspections

Tools & Technologies