Quality Assistant Manager for CMOs (m/w/d)
· Accountable for CMOs business continuity through PQR, change control, deviation, CAPA, stability monitoring, audit support, complaint support, QAA maintenance, CMO rating, Continuous Process Verification support, Risk Management, and support to product extensions in the CMOs of responsibility.
· Being the Product Expert and preventing and resolving quality problems with CMO and our interfaces.
· Accountable for CMO´s Regulatory Compliance and Quality System adherence and improvement through establishment and evaluation of Key Performance Indicators and Metrics.
· Appropriate investigations and CAPAs, participation in the preparation, execution and response to Quality audits and inspections, Standard Operational Procedure creation and assessment, recalls investigation, change controls reviews and effectiveness checks conduction, during the overall contract life cycle.
· Accountable for Quality Culture establishment and improvement through Quality Management Review, Training, Technical Visits, periodic meetings, Quality Audits support and partnership with Supply Chain, CMO Management and Regulatory Affairs.
· Several years of practical experience in a pharmaceutical industry
· GMP experience
· Good knowledge about quality systems and quality management systems, for applicable regulations
· Capability of dealing with complexity
· Fluent English Skills Bei der Zusendung von passenden Profilen an unsere Servicea
- Standort: Mainz
GULP Solution Services GmbH
Frau Ms. Suzan Algier
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