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- ...understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and...SuggestedRemote jobPermanent employmentFlexible hours
- ...colleagues in development of site contamination control strategies, aligned with global quality procedures and EU GMP Annex 1, FDA 21 CFR, ISO, and PIC/S. Provide subject matter expertise (SME) in microbiology, microbiological methods, contamination control, aseptic processing...SuggestedRemote jobFull timeWork at officeWorking Monday to Friday
- ...support validation activities for laboratory and manufacturing systems (LIMS, CDS, MES, EBR, QMS, etc.). Ensure systems comply with 21 CFR Part 11, Annex 11, and other applicable data integrity requirements. Review and approve user requirements, validation documentation,...SuggestedRemote jobWorldwide