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QA Systems Specialist
Grünenthal Group. Coordinate Change Control processes, ensuring timely assessment, implementation and effectiveness verification .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Assurance processes, including Change Control, GMP compliance, and risk management, while effectively communicating and collaborating with cross-functional teams to drive continuous improvement in quality standards.
Highest-signal resume keywords
Quality Assurance ExperienceGMP ComplianceRegulatory ComplianceRisk AssessmentCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Change Control ProcessesProduct Quality ReviewsProcess Validation ProtocolsCAPA ImplementationQuality KPIs Monitoring
Soft Skills
CommunicationInterfaces Management
Industry Keywords
Pharmaceutical SectorQuality AgreementsGMP StandardsInspection ReadinessQuality Risk Management
About the role
Key responsibilities & impact- Coordinate Change Control processes, ensuring timely assessment, implementation and effectiveness verification
- Support the development and execution of site training plans for GMP and quality compliance
- Coordinate preparation, review and approval of Product Quality Reviews (PQRs), identifying trends and improvement opportunities
- Plan and lead self-inspections, facilitating CAPA definition, implementation and effectiveness monitoring
- Provide QA oversight for Master Batch Records and associated GMP documentation
- Lead preparation and review of process validation protocols and reports with cross-functional teams
- Facilitate risk assessment activities and promote quality risk management across site operations
- Provide strategic QA support for qualification and validation lifecycle activities
- Oversee Quality Agreements with customers and external partners
- Support regulatory compliance activities and maintain readiness for inspections and manufacturing license requirements
- Monitor and trend site Quality KPIs, identify improvement areas and drive action plans
- Act as a key QA interface with internal stakeholders, promoting quality, compliance and continuous improvement
Requirements
What you’ll need- Degree in Scientific disciplines
- Minimum 3 years of experience in Quality Assurance positions within the pharmaceutical sector
- Knowledge of local and international legal/regulatory requirements and GMP standards
- Competency in communication and interfaces management
- Fluent English
Benefits
Comp & perks- Performance-based annual bonus
- Equal employment opportunities