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IT GxP Compliance Specialist, (Smith & Nephew, Inc., Memphis, TN): The main role of the IT GxP Compliance Specialist is to ensure that the global IT organization is in compliance with all applicable healthcare laws and regulations with a focus on computer systems validation. The IT GxP Compliance Specialist will assist in coordinating and facilitating internal and external audits of IT. In this role, it is necessary to work with auditors in addition to Regulatory, Quality, Finance, IT, and other personnel as required. The IT GxP Compliance Specialist will support and adhere to all IT policies, procedures and standards, including but not limited to, IT Guiding Principles, Project Management, Change Management, Internal and External Compliance such as Health & Safety, Quality, Regulatory and Finance, and support of Internal and External Audits.
Minimum Requirements:
Must have a Bachelor’s degree in Clinical Research Administration, Pharmaceuticals or related life science field, plus minimum of 6 years of post-baccalaureate experience in the job offered or related role in quality computer system/software validation delivery and oversight.
Of the required experience, must have 6 years of experience in each of the following:
– IT Computer Systems Validation (CSV) procedures
– Consultation and governance in the areas of regulatory requirements and Computer System/Software Validation
– Application of GAMP5 and Cloud computing in a healthcare environment
– Quality System Regulation and non-product Computer Software Validation in compliance with regulations such as FDA CFR 21 Part 820 / Part 210 / Part 211 / Part 11 and ISO 13485
Of the required experience, must have 2 years of experience in each of the following:
– IT infrastructure implementation and qualification
– Conducting external and internal IT and/or quality audits
– Software Lifecycle Management Software tools such as Veritas or ALM
– Electronic Document Management System such as IQVIA, Matrix or Master Control
Of the required experience, must have 1 year of experience in each of the following:
– IT cloud computing
– Change Management Software Tools such as ServiceNow or Remedy
Must be willing and able to travel up to 10% of the time (75% domestic; 25% international) to attend workshops, project-related meetings, and client site visits and/or audits.
Telecommuting permitted.
How to apply: Apply online at https://www.smith-nephew.com/careers/ click on vacancies and search IT GxP Compliance Specialist (REQ: R71982).
Minimum Requirements:
Must have a Bachelor’s degree in Clinical Research Administration, Pharmaceuticals or related life science field, plus minimum of 6 years of post-baccalaureate experience in the job offered or related role in quality computer system/software validation delivery and oversight.
Of the required experience, must have 6 years of experience in each of the following:
– IT Computer Systems Validation (CSV) procedures
– Consultation and governance in the areas of regulatory requirements and Computer System/Software Validation
– Application of GAMP5 and Cloud computing in a healthcare environment
– Quality System Regulation and non-product Computer Software Validation in compliance with regulations such as FDA CFR 21 Part 820 / Part 210 / Part 211 / Part 11 and ISO 13485
Of the required experience, must have 2 years of experience in each of the following:
– IT infrastructure implementation and qualification
– Conducting external and internal IT and/or quality audits
– Software Lifecycle Management Software tools such as Veritas or ALM
– Electronic Document Management System such as IQVIA, Matrix or Master Control
Of the required experience, must have 1 year of experience in each of the following:
– IT cloud computing
– Change Management Software Tools such as ServiceNow or Remedy
Must be willing and able to travel up to 10% of the time (75% domestic; 25% international) to attend workshops, project-related meetings, and client site visits and/or audits.
Telecommuting permitted.
How to apply: Apply online at https://www.smith-nephew.com/careers/ click on vacancies and search IT GxP Compliance Specialist (REQ: R71982).
