Responsibilities: Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance. Conducts real time batch record reviews in as...
Responsibilities: Serve as QA electronic system validation expert and will provide oversight and guidance on computer systems validation in accordance with applicable regulations, guidelines, policies and procedures. Train, support and a...
Responsibilities: Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory require...
Responsibilities: Support multiple Global Regulatory project teams and key sub-teams; provide functional expertise to GRLs and matrix early development teams. Collaborate with Client regional and country regulatory affiliates to support ...
Responsibilities and Requirements: Non-Conformances events including CAPA management when required. Local Factory level QMS Process owner for Process validation. Partner with SQ on incoming, outgoing, WIP Receiving Inspection /WIP inspe...
Responsibilities: Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate. Manages data management timelines to coordinate and synchronize deliverables with ...
Responsibilities: Author, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA/AAMI/ISO/EN guidelines/standards. Actively participate in all phases of proce...
Responsibilities: Collaborate closely with business stakeholders to gather and document requirements for regulatory operational projects. Analyze business processes and identify opportunities for improvement and automation. Develop and ...