Regulatory Compliance Specialist - Electronic Systems

At Proclinical, we are seeking a dedicated individual to fill the role of Regulatory Compliance Specialist - Electronic Systems, based in Foster City, CA.

Responsibilities

• Assist members of Electronic System Compliance in providing quality and compliance oversight for computer system validation and electronic records/electronic signatures compliance programs.
• Conduct electronic record and signature assessments and assist the business areas and IT in developing corrective action plans.
• Ensure up-to-date computer system inventories and assessments of regulated systems are maintained.
• Develop procedures for validation, electronic record and electronic signature compliance, electronic systems compliance, and/or IT operational procedures.
• Assist with CRO/service provider audits, audits of software vendors and in-house audits.

Skills And Qualifications

• BS with 5 to 7 years of experience or MS with 4 years of experience.
• Experience in the biotechnology/pharmaceutical or related, implementing and validating computer systems that manage regulated information.
• Experience in validation of COTS and in-house developed computer systems.
• Experience in prospective and retrospective computer system validation.
• Experience in performing 21 CFR Part 11 and Annex 11 assessments 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.
• Experience with validating relevant systems.
• Knowledgeable in 21 CFR Part 11, GCP, GLP, and GMP regulations.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Christopher Frank at (+1) 2674056996 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.