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QA Systems Specialist
Grünenthal GroupQA Systems Specialist ensuring quality assurance compliance for pharmaceutical manufacturing processes. Engaging in quality management and regulatory requirements within a collaborative international team environment.
ATS Keywords
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Hard Skills
change control managementProduct Quality Review (PQR)Master Batch Records revisionprocess validation protocolsrisk assessment managementqualification documentation revisionvalidation documentation revisionregulatory managementKPI collection
Soft Skills
communicationinterfaces management
Industry Keywords
Quality Assurancepharmaceutical sectorGMP standardslocal legal requirementsinternational legal requirements
About the role
Key responsibilities & impact- management of change controls
- participation in planning and execution of site trainings
- issuance and revision of Product Quality Review (PQR)
- participation in planning and execution of self-inspections together with CAPA management
- revision of Master Batch Records
- issuance of process validation protocols and reports
- participation in risk assessment management
- cooperation in the revision of qualification and validation documentation
- overview on Quality Agreement with customers
- participation in management of regulatory aspects to maintain required manufacturing licenses
- collection of site KPIs
Requirements
What you’ll need- degree in Scientific disciplines
- 3–5 years of experience in Quality Assurance positions within the pharmaceutical sector
- knowledge of the local and international legal/regulatory requirements and GMP standards
- competency in communication and interfaces management
- fluent English
Benefits
Comp & perks- performance-based annual bonus