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CSV Specialist

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 
United States

Offer summary

Qualifications:

Bachelor's degree in relevant field, 3-5 years experience in Life Sciences Industry.

Key responsabilities:

  • Provide CSV advisory and training
  • Assess Protocol Exceptions and assist testers
  • Maintain integrity and work nights/weekends
Katalyst HealthCares & Life Sciences logo
Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/
51 - 200 Employees
About Katalyst HealthCares & Life Sciences
Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing
See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:
  • CSV advisory for the planned projects
  • Training of testers and approvers of CSV processes and systems
  • Perform Protocol Exception Assessments and Resolutions
  • Provide support to testers, as needed, with validation questions.
  • At all times, exemplify the highest level of business and personal integrity
  • Must be able to work nights & weekends
  • Bachelor of Science in an Engineering, Computer Systems or Science Field
Requirements:
  • 3-5 years experience as a CSV specialist within the Life Sciences Industry
  • 1-2 years experience with ERP validation, SAP S/4 HANA experience preferred
  • Knowledgeable in US and Global Computer system Validation requirements
  • Knowledge of GAMP 5 methodology
  • Experience with ValGenesis, preferred
  • Detail-oriented with ability to accomplish objectives.
  • Demonstrated ability to work independently.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Computer System ValidationERP Systems KnowledgeSAP HANA

Other Skills

  • Detail Oriented
  • Verbal Communication Skills
Are you interested?

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