Regulatory Compliance Associate - II
Job Description
Description :
Check you match the skill requirements for this role, as well as associated experience, then apply with your CV below.
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.
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