Diverse Lynx
Validation Lead
Diverse Lynx, Indianapolis, Indiana, us, 46262
Job Title:
Validation LeadLocation: Indianapolis, IN - OnsiteDuration: ContractJob Description
Role name:
Lead
Role Description:
•Work in partnership with the Global IT team and site representatives to understand business needs and implement innovative solutions to add value to the site while maintaining computer systems in a validated state.•Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX•Periodic Review of PMX- March and Oct.•DI Documentation Project- Update security plans and any other documentation
Competencies:
Life Sciences : Computer System Validation, Healthcare : Pharmacy, Communication, Regulatory IT Compliance
Experience (Years):
8-10
Essential Skills:
•Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX•Periodic Review of PMX- March and Oct.•DI Documentation Project- Update security plans and any other documentation.•SIA of LQPs and other Global documents.•ARR for the computer systems.•Assist with any CSV project in the Compliance Map as needed.•Periodic review of CVM and DS
Desirable Skills:
? Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable.? Experience of working in virtual teams across different cultures and geographies ? Experience of working with cloud-based technologies is desired
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
Validation LeadLocation: Indianapolis, IN - OnsiteDuration: ContractJob Description
Role name:
Lead
Role Description:
•Work in partnership with the Global IT team and site representatives to understand business needs and implement innovative solutions to add value to the site while maintaining computer systems in a validated state.•Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX•Periodic Review of PMX- March and Oct.•DI Documentation Project- Update security plans and any other documentation
Competencies:
Life Sciences : Computer System Validation, Healthcare : Pharmacy, Communication, Regulatory IT Compliance
Experience (Years):
8-10
Essential Skills:
•Quarterly Audit Trail review of IPM systems- FOP, DSA, CVM, and PMX•Periodic Review of PMX- March and Oct.•DI Documentation Project- Update security plans and any other documentation.•SIA of LQPs and other Global documents.•ARR for the computer systems.•Assist with any CSV project in the Compliance Map as needed.•Periodic review of CVM and DS
Desirable Skills:
? Risk Management, Supplier evaluation and assessment and auditing experience is highly desirable.? Experience of working in virtual teams across different cultures and geographies ? Experience of working with cloud-based technologies is desired
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.