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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- GMP
- cGMP
Noch nicht perfekt?
- 1201 F. Hoffmann-La Roche AGVollzeitnur vor OrtBerufserfahrenKaiseraugst
- 1201 F. Hoffmann-La Roche AG
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QA Manager für das Quality System und Compliance in Central Certification(m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahrenGrenzach - 1201 F. Hoffmann-La Roche AG
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Vollzeitnur vor OrtSeniorBasel
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- GMP
- cGMP
Über das Unternehmen
F. Hoffmann-La Roche AG
Branche
Pharmaceuticals
Beschreibung
Roche is dedicated to advancing science and ensuring access to healthcare, developing innovative drug products and solutions to prevent, stop, and cure diseases.
Noch nicht perfekt?
- 1201 F. Hoffmann-La Roche AG
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