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Regulatory Compliance Associate - II

Company: Katalyst Healthcares & Life Sciences
Location: Sunnyvale
Posted on: February 22, 2021

Job Description:

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Description:
    • Regulatory Compliance Specialist - Electronic Systems Essential Duties and Job Functions:
      • Assist members of Electronic System Compliance in providing quality and compliance oversight for the computer system validation and the electronic records / electronic signatures compliance programs
      • Conduct electronic record and electronic signature assessments and assist the business areas and IT in developing corrective action plans
      • Work to ensure that up-to-date computer system inventories and assessments of regulated systems are maintained
      • Assist with CRO/service provider audits, audits of software vendors and in-house audits, any of which may require travel Education and experience:
        • BS with 3 to 5 years of experience
        • MS with 2 years of experience Specific Knowledge and Skills Required:
          • Previous experience in the biotechnology / pharmaceutical or related industry implementing and validating computer systems that manage regulated information
          • Experienced in the validation of COTS and in-house developed computer systems
          • Experienced in prospective and retrospective computer system validation
          • Experienced in performing 21 CFR Part 11 and Annex 11 assessments (gap analyses) and developing corrective action plans
          • Knowledgeable with software development life cycles and other IT related development practices
          • Working knowledge of IT infrastructure qualification processes and IT operating procedures
          • Experienced in using, implementing, and/or validating systems, such as: drug safety, medical/drug coding, clinical trial management, clinical information, electronic data capture, electronic diary, radiological reading, laboratory information management, computerized laboratory instrumentation, document/enterprise content management, submission publishing, electronic transfer/exchange, structured product labeling, training records, CAPA, and audit tracking
          • Experienced in developing procedures for validation, electronic record and electronic signature compliance, electronic systems compliance, and/or IT operational procedures
          • Knowledgeable in 21 CFR Part 11, GCP, GLP, and GMP regulations. Additional Information All your information will be kept confidential according to EEO guidelines. Other jobs at Katalyst Healthcares & Life Sciences

Keywords: Katalyst Healthcares & Life Sciences, Sunnyvale , Regulatory Compliance Associate - II, Other , Sunnyvale, California

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