What are the responsibilities and job description for the Validation Lead position at Katalyst HealthCares & Life Sciences?
Responsibilities
- 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.
- Life Sciences: Computer System Validation, Healthcare: Pharmacy, Communication, Regulatory IT Compliance.
- 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 DSA
- Risk Management, Supplier evaluation, 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.
Service Support Specialist
Validation Associates -
Indianapolis, IN
Customer Support Engineer
Validation Associates -
Indianapolis, IN
Lead Senior Computerized System Validation CSV Consultant
cGxPServe -
Indianapolis, IN
