Description / Duties:
- Prana Life Sciences LLC is an ISO-9001 and ISO-27001 certified technology company serving the life sciences industry. We are hiring a GxP Validation Engineer to help validate our life sciences clients’ computer systems.
- The GxP Validation Engineer will be responsible for helping to develop quality management systems needed for the highly regulated life sciences industry. It will include development of policies, manuals, procedures, work instructions, checklists, forms, and quality documentation templates.
- The GxP Validation Engineer will develop validation artifacts for IT systems. These artifacts will include Risk Assessment Reports, System Validation Plan (SVP), User Requirement Specifications (URS), Configuration Specifications (CS), Test Plans (TP), User Acceptance Test (UAT), Test Scripts (TS), Trace Matrix (TM), Validation Summary Report (VSR), etc.
Qualification – Must have’s:
- At least 3-5 years of experience performing Computer System Validation for the Life Sciences Industry
- Bachelor’s degree in a related field
- Expertise in development of IQ/OQ/PQ validation protocols and validation documentation such as System Validation Plan (SVP), User Requirement Specifications (URS), Configuration Specifications (CS), Test Plans (TP), User Acceptance Test (UAT), Test Scripts (TS), Trace Matrix (TM), Validation Summary Report (VSR), etc.
- Worked for life sciences, healthcare and information technology ensuring compliance to GxP, 21 CFR Part 11, HIPAA, EDQM, ICH, GDPR, ISO, CE, NABH, CMMI and various other regulatory requirements
Qualification – Good to have’s:
- At least 1-2 years of Veeva Vault experience is preferred
- Experience of configuration and data migration for Veeva Vault Quality Suite, Clinical Suite , Regulatory (RIM) Suite, PromoMats, MedComms, etc.
Benefits
- Salary will be at par the current market depending on candidate qualification
- The employee will be entitled to all standard benefits offered to the employees of Prana Life Sciences LLC
Prana Life Sciences is an E-Verify employer. We take compliance very seriously.
To Apply, please submit your resume to HR@prana4life.com
