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 Validationdocumentation 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 forcomputerized 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
Qualifications:
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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