COMPANY: HCL AMERICA INC.
JOB TYPE: Contract, FullTime
This position is responsible for leading and performing validation activities for Oracle EBS in GxP quality and compliance environment.
Should have experience in Oracle eBS funstional testing/analysis.
Perform GxP assessment and create Validation Plan
Perform overall and detailed risk assessment
Prepare and/ or review functional and design specifications.
Prepare and reviews test protocols such as IQ, OQ, PQ
Lead overall protocol (IQ/OQ) executions. Log and track deviations.
Review and approval of executed protocols (IQ/OQ)
Review and approve validation summary report
Ensure GxP Computerized Systems are in qualified/validated state as per GAMP -5/client s requirements.
Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
Maintain overall project and issue tracker and report routinely.
Desired skills / certifications / training
8+ years in Computer System Validation, writing policies/procedures in Life Science domain.
Oracle EBS functional knowledge
Excellent knowledge of cGMPs, FDA and EMEA guidelines including 21 CFR Part 820, 21 CFR Part 11
Excellent knowledge of computer system validation and GAMP -5 standards.
Should be able to work independently. Excellent communication skills.
Prior experience in working with large global teams.
- provided by Dice