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 Senior IT Quality Systems Analyst for our software product development projects.
- The Senior Quality Systems Analyst will be responsible for ground up development of quality management systems needed for highly regulated life sciences industry. It will include development of policies, manuals, procedures, work instructions, checklists, forms, and quality documentation templates.
- The Senior Quality Systems Analyst will be responsible for the software product design, development, delivery, and services in compliance with the ISO standards and FDA regulations.
- The Senior Quality Systems Analyst will act as a liaison among the business, IT, and compliance teams to ensure adherence to the highest level of quality practices.
- The Senior Quality Systems Analyst will perform regular internal quality reviews, inspections and audits of all teams and functions across the organization.
- The Senior Quality Systems Analyst will work with software product architects and engineers to develop self-validating quality functions of software products.
- The Senior Quality Systems Analyst will deliver validation artifacts for IT systems used in the organization, as well as software products developed in house. 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.
- The Senior Quality Systems Analyst will provide guidance to the engineers for Veeva platform usage and integration with our in-house products.
Qualification – Must have’s:
- At least 15 years of experience in IT and Quality organizations.
- At least Graduate Engineering Qualifications.
- Proven track record in leading ISO audits, inspections and internal quality reviews.
- Veeva Vault Platform White-belt Certification.
- More than 10 years of QMS development, training, implementation, auditing, computer system validation, data governance, information security, project management and systems certification experience.
- Experience of implementation of Veeva Vaults such as Veeva Vault Quality, Clinical, Regulatory, and Commercial.
- 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.
Qualification – Good to have’s:
- Post graduate engineering/management or doctoral qualifications
- 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
- Experience of configuration and data migration for Veeva Vault Quality (QualityDocs, QMS, Training), Clinical (CTMS/eTMF), Regulatory, PromoMats, MedComms, etc.
- Six Sigma and high maturity statistical credentials
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
