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Responsibilities
Under general direction, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines
- Develops, maintains and improves GMP-related quality control systems including standard operating procedures (SOPs)
- Participates in project teams to provide review and approval of project Validation documentation according to applicable approval matrix or procedures
- Supports quality systems related to Validation, LIMS, Calibration, Document Management, Deviation Management, CAPA, Change Control, and Enterprise Learning Management
- Writes and manages validation plans, ensuring appropriate, timely validation/revalidation is maintained
- Conducts internal audits and assists with 3rd party quality audit; plans and implements continuous improvement projects
- Supports GxP health authority inspections by serving as subject matter expert for computerized systems topics
- Provides guidance on quality and regulatory requirements to project teams, internal stakeholders and other teams on GxP compliance relating to computerized systems
- Collaborates to resolve technical issues, provide quality training and communicate best practices
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Qualifications
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- Bachelor degree in Engineering or a relevant scientific discipline (Chemistry, Biology, Microbiology, IT etc.) or equivalent experience
- 5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment
- Knowledge of current Good Manufacturing Practices (cGMP)
- Knowledge of FDA and EMA requirements
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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