harmonization and standardization across global sites to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, ISO... of global quality systems that support compliance, operational excellence, and risk mitigation across the pharmaceutical product...
& Inspection Readiness Ensure full compliance with GMP, GDP, ICH, FDA, EMA, and global regulatory requirements Maintain... SUMMARY The Vice President, Supply Chain is responsible for the end-to-end strategy, execution, and governance of global...
datasets. Prepare submission artifacts (reviewer's guides, Define.xml, annotated CRFs) aligned with FDA/EMA expectations... as an Applicant in the United States. Capgemini is a global business and technology transformation partner, helping organizations...
, protocols (DQ, IQ, OQ, PQ) summary reports, and validation master plans/reports. As member of globalengineering team, strongly... connecting and involving in DP globalengineering projects planning and implementation. Regulatory Compliance Ensure all CQV...
, and validation master plans/reports. As member of globalengineering team, strongly connecting and involving in DP global... regulatory and quality standards (FDA, EMA, ICH) and are in a state of control throughout their lifecycle. The ideal candidate...
through development, database lock, and reporting/submission. Deep understanding of ICH-GCP, FDA, EMA, and other global... approach—one that integrates expertise across social, statistical, data, and laboratory sciences, engineering...
assessment, protocols (DQ, IQ, OQ, PQ) summary reports, and validation master plans/reports. As member of globalengineering... team, strongly connecting and involving in DP globalengineering projects planning and implementation. Regulatory...
of accountability and operational excellence across all assigned facilities. Job Description: Support the implementation of global... facilities. Your Profile Education and Experience: Bachelor’s degree in Life Sciences, Quality Management, Engineering...
to ensure compliance with global regulatory standards. The role involves managing validation lifecycle activities, coordinating... audits & inspections (FDA, EMA, MHRA) Manage change control, deviation, CAPA related to validated systems Mentor and guide...
goals and ensure high performance. Oversee daily aseptic manufacturing operations, ensuring compliance with FDA, EMA..., and other global regulatory requirements. Maintain strict adherence to cGMP, SOPs, and aseptic processing standards. Partner...