quantitation of desired analytes. Write and review standard operating procedures and coordinate method development and validation...
The incumbent will be a part of the IT Computerized System Validation (CSV) Department and will perform and/or direct... GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. This individual...
Responsibilities: Scope of Services: SDTM, ADaM, and TLF production and/or validation, Ad-hoc from statistics... guidelines on data and reporting standards. SDTM, ADaM, and TLF production and/or validation alignment of processes...
facility team in maintaining equipment. Assist the validation team in conducting facility and equipment validations. Perform...
agencies. Support the facility team in maintaining equipment. Assist the validation team in conducting facility and equipment...
Responsibilities: Develop Test/Validation Master Plan and test strategies. Develop detailed Test/Validation scripts... or blockers. Requirements: Strong understanding of FDA guidance on electronic records and validation procedures. Experience...
Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO... development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database...
for their applicability to identified user needs. Represents IT in collaboration with Quality Validation and business stakeholders... to determine computer system validation (CSV) impact, requirements, and artifacts. Executes and facilitates GxP Computer System...
manufacturing process. Reviews and approves batch records, validation protocols, data, and reports. Requirements: Demonstrated...
and implement ETL routines according to the Data Warehouse (DWH) design and architecture. Support the development and validation...
with process and equipment validation. AutoCAD and SolidWorks experience preferred....
. Oversee the calibration management program and coordinate with vendors to ensure timely execution. Validation Management...: Plan, track, and schedule validation activities. Approve and oversee validation protocols and coordinate scheduling...
and validation for the quality reports. Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers...
structures, and data exchange with multiple data formats. Expertise in performing validation of datasets, and TFLs using risk...
that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant! Together..., business process knowledge, and consulting excellence. As a Computer Systems Validation (CSV) Consultant...
or consumer packaging. Knowledge and understanding of packaging design validation standards (ISO, ASTM, etc.), drafting...
QUALITY ANALYST: • A minimum of 4-6 years of related experience. Must have Process Validation experience. Good... of GMP/ISO regulations and validation regulations The ability to perform 'hands on' troubleshooting and problem solving...
Author or revise SOPs, qualification/validation protocols and reports. Asist with lab investigations regarding out...
and implementation guidelines, able to create and validate CDISC standard datasets. Experience creating source and validation programs...