processes, process validation, computer and equipment validation, and GMPs. Ability to develop clear, concise, and timely oral...: This position has responsibility and authority for:Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices...
Experience with Test Method Validation and/or Measurement System Analysis is preferred. Knowledge of computer software for the... qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation, and Production Validation of test...
Responsibilities and Requirements: 5+ yrs testing/validation experience with LS background. Strong knowledge... of Pharma CSV (Computer Systems Validation). Knowledge of CSA (Computer system Assurance). Work with business users...
Responsibilities and Requirements: 9+ yrs testing/validation experience with LS background. Strong knowledge... of Pharma CSV (Computer Systems Validation) Knowledge of CSA (Computer system Assurance). Work with business users...
Responsibilities: We are seeking a skilled Validation Engineer with experience in GxP compliance and expertise in 21... regulatory standards. Ensure compliance with GxP (Good Practice) guidelines and 21 CFR Part regulations. Perform validation...
. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation.... Facilitates the validation process and implementation of system upgrades, including guiding, testing, supporting the introduction...
, as needed, with validation questions. At all times, exemplify the highest level of business and personal integrity. Must be able to work nights... with ERP validation, SAP S/4 HANA experience preferred. Knowledgeable in US and Global Computer system Validation requirements...
analysis of any discrepancy reports generated during validation execution and proposing CAPA's. Requirements: Bachelor...'s degree in life sciences or engineering. 5+ years of validation experience in a cell and gene therapy GMP environment...
validation team and be responsible for the validation of automated equipment and control systems Create and modify validation... Revew Retirement Summary review Deliverables: Requirement document Validation/Test Plan Requirement Traceability Matrix...
, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team... and be responsible for the validation of automated equipment and control systems. Create and modify validation documentation including...
for CSV and Process Validations · Support the development of the qualification and validation programs at Just including the... transition from paper based to digital validation software to configure globally scalable end to end paperless solutions...
Responsibilities: Provide Quality oversight for the Commercial stage, including Design Transfer. Create/revise/execute SOPs to support combination product quality governance in the commercial stage. Evaluate design changes and provide q...
and validation experience while authoring the protocols. Why work here? They are a growing company that provides above market...
and validation experience while authoring the protocols. Why work here? They are a growing company that provides above market...
documentation, data management plan (DMP), CRF, study database specifications, data validation plan, edit check specifications, data...
such as verification and validation test protocols/reports, risk management reports, and product labeling. Pragmatic with strong problem...
following CDISC standards Develop SAS programs for the creation of Tables, Listings and Figures. Validation of ADaM data sets.... Validation of Tables, Listings and Figures. Create specifications for the structure of ADaM data sets for individual studies...
for reviewing the data management documentation, data management plan (DMP), CRF, study database specifications, data validation...
, SAS/STAT and SAS/GRAPH. Experience in development and validation of CDISC SDTM and ADaM data models by transforming raw... data into standard domains and development and validation of Tables/Listings/Figures. Extensive experience of data...
, validation and support Perform duties as assigned Ensure compliance with all company standards and policies...