
Digital System Validator
6 days ago
We are seeking a seasoned professional to join our organization as a Senior Manager. As a key member of the team, you will be responsible for performing and documenting Computer System Validation of GxP Systems according to defined processes.
About this role:
- Validate computer systems to ensure compliance with regulatory requirements
- Create end-to-end validation deliverables for IT projects (e.g., URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment)
- Liaise with stakeholders to ensure project timelines are met
Key Responsibilities:
- Perform root cause analysis and define CAPA based on QMS documents review
- Guide and train teams for CSV, and CSV Regulatory Compliance activities
- Collaborate with business, IT, quality and project managers to ensure project success
Requirements:
- Graduate in Science/Pharmacy/Engineering
- Post-Graduation - MPharm/Science/MBA (Desirable)
- 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity
Preferred Qualifications:
- Experience in working with various geographical locations and cross-functional sites
- Experience of validation on automation/digitization projects
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