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...
registration requirements. As a regulatory process expert supporting global registrations the candidate interprets federal/state... such as verification and validation test protocols/reports, risk management reports, and product labeling. Pragmatic with strong problem...
and join our global team! Are you ready to become a pivotal technology expert? As a Sr. Global Applications Manager, you will own the..., validation and support Perform duties as assigned Ensure compliance with all company standards and policies...
and join our global team! Are you ready to become a pivotal technology expert? As a Sr. Global Applications Manager, you will own the..., validation and support Perform duties as assigned Ensure compliance with all company standards and policies...
Responsibilities: Act as the subject matter expert on SDTM standards, providing guidance and recommendations to the... healthcare/life sciences domain. Deep technical understanding of SDTM data models, mappings, and validation rules. Experience...
to drive capabilities. Become functional/technical expert on LIMS and Biovia eLN archive (system features, system... to build a successful system Write FDA validation documentation (Validation Plans, IQ, IQ, PQ protocols, write or execute...
to drive capabilities. Become functional/technical expert on LIMS and Biovia eLN archive (system features, system... to build a successful system Write FDA validation documentation (Validation Plans, IQ, IQ, PQ protocols, write or execute...
quantitation of desired analytes. Write and review standard operating procedures and coordinate method development and validation... of MS analytical methods. Serve as Scientech mass spectrometry, GC-MS, and LC-MS subject matter expert (SME). Train MS Lab...
Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans, code terms in MedDRA and WHO... with limited information in conjunction with leadership; serve as the interdepartmental subject matter expert for the CDM area...
of shipping route verification studies per SOPs, supports investigations and CAPAs as technical expert in the Drug Product... manufacturing process. Reviews and approves batch records, validation protocols, data, and reports. Requirements: Demonstrated...
and validation for the quality reports. Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers...