SENIOR GLOBAL QUALITY AUDITOR (M/W/D)
Ageneo Life Science Experts, Hessen
Desired areas of expertise:
Global, innovative healthcare company with production site in Germany (Hessen) is looking for you as "Senior Global Quality Auditor" (m/w/d).
- Leads the planning and execution of internal quality audits according to relevant international standards and local regulations, and the companys global procedures.
- Assesses compliance of systems, processes and procedures with relevant audit criteria including global procedures and documents findings in audit reports.
- Assesses potential compliance risks, make risk-based decisions and communicates to the Auditee as well as the Management.
- Ensures audit reports are issued in a timely manner and adequate corrective / preventive actions proposed for implementation that address the root cause of identified deficiencies.
- Performs desktop audits.
- Knowledge transfer of peer reviews other auditors audit reports for completeness and overall quality
- Provides training
- Provides support to improve Internal Audits Quality System
- Leads and manages different Internal Audits projects
- Diploma or Master degree, preferably in a natural science such as in Chemistry, Pharmacy, Engineering or proven equivalent knowledge by long term job experience
- Profound knowledge in GXP regulations preferably in the US-FDA environment proven by either 10 years of operational experience in the health care industry or relevant Competent Regulatory Authority
- Good knowledge in sterile manufacturing and / or active devices and / or computerized system validation
- Knowledge of EU GMP and/or US FDA /regulatory requirements and expectations concerning manufacturing of Pharmaceuticals: excellent knowledge of cGxP (Eudralex Vol 4 and / or US 21 CFR 210/ 211)
- Strong interpersonal and communication skills, both written and verbal
- Fluent in English and preferably in another pertinent language
- Demonstrated ability to work collaboratively and cross functionally
- Demonstrated ability to make risk-based decisions
- Good report writing skillsInternational experience - a plus.
- Ability and readiness to travel domestically and internationally (up to 50% of work time), on occasions at short notice
- innovative, global company
- international position
- motivated Team
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