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Complaint Lead Investigator(m/w/x)
Processing external complaints for drug products in a pharmaceutical setting. Understanding of quality and compliance fundamentals essential. Focus on patient safety and product quality for life-saving drug products.
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
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- cGMP
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Complaint Lead Investigator(m/w/x)
Processing external complaints for drug products in a pharmaceutical setting. Understanding of quality and compliance fundamentals essential. Focus on patient safety and product quality for life-saving drug products.
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
Work Experience
- 2 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- cGMP
About the Company
F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Roche is dedicated to advancing science and ensuring access to healthcare, developing innovative drug products and solutions to prevent, stop, and cure diseases.
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