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 5 to 7 years of experience
MS with 4 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 . •
Last updated on Dec 4, 2020