, qualification/validation testing and support. Printed packaging materials plan ownership/management. Supporting product launches...
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...
Experience in Supporting Parenteral Manufacturing Operations. Previous Equipment Qualification and Process Validation Experience...
procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols and summary...
, and JMeter. Familiar with database testing and SQL scripting for data validation. Understanding of authentication and identity...
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...
, 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...
clinical / scientific execution of clinical protocol(s) / programs (including interventional, non-interventional, validation...
(cGMPs); 1 year of experience with cleaning validation, root cause investigation, and manufacturing statistics; 1 year... in compliance with SOPs, FDA/ICH guidelines, DEA regulations, and safety requirements for validation activities, and investigations...
impurities). Demonstrated registration stability, process validation, or post-approval process development leadership. Track...
, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs... business needs. Previous equipment qualification and process validation experience. Previous experience with deviation...
, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports... and mentoring. Previous equipment qualification and process validation experience. Previous experience with deviation and change...
Engineers are responsible for technical aspects of the design, delivery, and qualification/validation of the device assembly..., qualification/validation, and Computer System Validation: Automated Control Systems Expertise: PLCs, motion, HMIs, vision systems...
develops and reviews user requirements, design specifications, and system validation documents. Provides leadership...
creation, and process validation, as well as occasional testing activities typical for a cGMP pharmaceutical manufacturing... required for analytical method validation according to study protocols and standard operating procedures. Generate study reports...
. Build strong CM relationships to align on goals and expectations. Lead validation strategy, protocol approval, execution...
, identifying relevant tasks and data sources. Model Validation in MTL: Establish rigorous validation and evaluation frameworks...
organizations throughout the transfer, validation and implementation of immunogenicity and biomarker assays used in clinical trials... and biomarker assay development and validation and managing external vendors is a plus. Experience as bioanalytical/immunogenicity...
. Ensure strict adherence to corporate computer systems validation policies and procedures across all supply chain applications...
and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations... metrics for trends at the CM Support Qualifications/ Validation document creation and reviews Provide and coordinate...