The Grünenthal Group is an independent, family-owned, international research-based pharmaceutical company headquartered in Aachen, Germany. We are an entrepreneurial specialist delivering true benefits to patients. By sustainably investing in research and development above the industrial average, we are committing to innovation in order to treat unmet medical needs and bring value-adding products to markets. Grünenthal is a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients.
Post: GMP QA Manager
Responsibilities:
Main focus of the position is the support of the Grünenthal Quality Assurance team in development, maintenance and improvement of Quality Management Systems (e.g. Deviation Management, Root Cause Analysis, CAPA Effectiveness and Complaint Handling for Medical Devices and Medicinal Products). This position will also support all relevant GMP departments in Aachen in the execution of those Quality Management Systems.
- Contact person for Deviation Management, Root Cause Analysis and CAPA Effectiveness for all relevant GMP departments, mainly Drug Substance and Drug Product Production, Quality Control, Warehouse and Logistics
- Perform trend analysis about the development of deviations, root causes and CAPAs and assessment of these parameters’ changes
- Perform operational tasks within the GMP Quality Assurance concerning several Quality Management Systems, mainly Change Control Procedures, Deviation Management and Complaint Handling Support all other Quality Management Systems on operational level (e.g. Supplier Qualification Program and Product Quality Review creation).
Candidate Profile
- Successfully concluded studies of pharmacy (qualified pharmacist) or an equivalent qualification (natural sciences or engineer with pharmaceutical industry background)
- Sound experience in the pharmaceutical industry, thereof several years of experience within GMP Quality Assurance
- Self-dependent and independent method of operation and decision taking
- High social competence, team spirit and negotiating skills
- German and English business fluent spoken and written
- Profound MS Office knowledge (Outlook, Word, Excel)
- SAP experience in the Quality Management Module
- Trackwise experience.
Additional info:
Qualification: B.Pharm, M.Pharm, D.Pharm
Location: Germany - Aachen
Area: QA
Requisition Number: 2301
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