Requisition ID 16154BR
Title IT Compliance Analyst
Job Category Information Technology
Job Description Position Purpose:
Serve as IT’s primary point of contact and subject matter expert (SME) on all IT and automation related compliance policies and programs. To become the site’s expert on implementation, training and support of eTIMS validation software. To assist with the development and execution of key IT and automation projects.
Education: BS in IT, CIS, MIS, Engineering or other technical science field + 5 to 10 years experience
Experience:
•Experience with software development concepts
•Proven experience with quality systems
•Proven problem solving skills.
•Excellent organizational skills.
•Excellent written and verbal communication skills.
•Knowledge of FDA regulations and guidelines as they relate to computer-based information systems
•Experience working in pharmaceutical manufacturing environment
Technical/Process/Functional Knowledge/Responsibilities:
•In-depth knowledge and training on compliance policies, programs and procedures as well as regulatory requirements, such as 21 CFR Part 11, electronic records retention, configuration items lists, revalidation, etc.
•Experience with quality procedures such as non-conformities, change requests, and IT system validation
•Serve as the liaison between IT/automation and both internal and external QA organizations as well other IT auditing organizations
•Knowledge of pharmaceutical manufacturing business processes and how IT and automation integrate with them
•Excellent troubleshooting skills; can identify root cause of a problem and assist in determining appropriate IT or technical solutions
•Demonstrated skills in identifying and leading medium to large scale IT validation projects
•Possesses and applies a broad range of expertise of principles, methods, practices, standards, procedures and compliance requirements of a particular business function in designing and developing complex IT solutions
•Provides solutions which are aligned with site strategies and comply with the company’s architectural and operating standards and requirements.
•Experience with developing and maintaining IT-focused policies, procedures and other documents
Physical Requirements:
Ability to work hours necessary to support continuous operations.Interface with all business units to obtain/relay information.
Develop robust business relationships and contacts with outside vendors and contractors.
Overseas travel (estimated at 15% or less)
Department IT Systems
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%
Title IT Compliance Analyst
Job Category Information Technology
Job Description Position Purpose:
Serve as IT’s primary point of contact and subject matter expert (SME) on all IT and automation related compliance policies and programs. To become the site’s expert on implementation, training and support of eTIMS validation software. To assist with the development and execution of key IT and automation projects.
Education: BS in IT, CIS, MIS, Engineering or other technical science field + 5 to 10 years experience
Experience:
•Experience with software development concepts
•Proven experience with quality systems
•Proven problem solving skills.
•Excellent organizational skills.
•Excellent written and verbal communication skills.
•Knowledge of FDA regulations and guidelines as they relate to computer-based information systems
•Experience working in pharmaceutical manufacturing environment
Technical/Process/Functional Knowledge/Responsibilities:
•In-depth knowledge and training on compliance policies, programs and procedures as well as regulatory requirements, such as 21 CFR Part 11, electronic records retention, configuration items lists, revalidation, etc.
•Experience with quality procedures such as non-conformities, change requests, and IT system validation
•Serve as the liaison between IT/automation and both internal and external QA organizations as well other IT auditing organizations
•Knowledge of pharmaceutical manufacturing business processes and how IT and automation integrate with them
•Excellent troubleshooting skills; can identify root cause of a problem and assist in determining appropriate IT or technical solutions
•Demonstrated skills in identifying and leading medium to large scale IT validation projects
•Possesses and applies a broad range of expertise of principles, methods, practices, standards, procedures and compliance requirements of a particular business function in designing and developing complex IT solutions
•Provides solutions which are aligned with site strategies and comply with the company’s architectural and operating standards and requirements.
•Experience with developing and maintaining IT-focused policies, procedures and other documents
Physical Requirements:
Ability to work hours necessary to support continuous operations.Interface with all business units to obtain/relay information.
Develop robust business relationships and contacts with outside vendors and contractors.
Overseas travel (estimated at 15% or less)
Department IT Systems
Position Location US - Clayton, NC
City clayton
State/Provinces US - NC
Degree Required Bachelor's Degree Required
Percent Travel 10 - 20%