reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging..., change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc. Minimum Qualifications...
, Clinical Data Manager and other key partners to deliver standardized data collection methods and innovative validation... in clinical data management, database programming or system validation experience in the clinical, pharmaceutical, biotech, CRO...
Foundry are compliant with current computer systems validation expectations. This will include coordinating with the Foundry... of computer systems validation support, including System Development Lifecycle knowledge, problem solving, project management...
clinical / scientific execution of clinical protocol(s) / programs (including interventional, non-interventional, validation...
. Ensure strict adherence to corporate computer systems validation policies and procedures across all supply chain applications...
guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site...
impurities). Demonstrated registration stability, process validation, or post-approval process development leadership. Track...
of process validation protocols and reports, approval of validation master plans, approval of risk-based rationale if bracketing... of products is used for cleaning validation, etc.) Ensure adequate quality oversight for manufacturing operations...
procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols and summary...
system validation. In addition to creation, execution, and coordination of validation activities in unison with contract...
and/or engineering changes, including the creation of validation test plans. Ensures all assigned product certifications and listings...
projects, train maintenance and production personnel, conduct pilot and validation activities following Roche Diagnostics... for each project Ensures process changes are characterized and implements following validation policies and procedures Assures...
of assigned projects. ·Support commissioning, qualification, and validation activities when applicable ·Provide technical... support during Startup, PQ and validation activities ·Support change requests/change control as needed ·Support internal...
System Validation (CSV). Experience in line qualification Test Protocols (IQOQPQ) and Process Validation (PV... to ensure seamless integration of automation systems. Maintain and update system lifecycle documentation and validation...
, and validation of allocation/replenishment calculations and logic that improves inventory productivity and business results. Develop...
in validation of new processes or new equipment. Reviews daily work for accuracy and recognizes unexpected results, resolving...
, and validation of allocation/replenishment calculations and logic that improves inventory productivity and business results. Develop...
effectively and that a robust process for cost validation is in place. Carrying out the production of monthly cost reports...
, understand production process validation, are self-driven, desire to solve problems, have the ability to implement effective... downtime Assist in validation efforts for commissioning of process improvements Participate in Lean manufacturing training...
adequate coverage. Oversee validation of products and materials ordered for projects to verify their conformance...