Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & Responsibilities:
- 15+ years of experience in Pharma IT and SAP environments.
- Strong knowledge of CSV, GxP, and regulatory frameworks.
- Proven leadership in quality assurance and validation.
- Validation Oversight: Author and approve key validation deliverables (e.g., Deliverable Scaling Assessment, CRs, lifecycle documents, test artefacts).
- Strategic Quality Leadership: Define validation strategies with SMEs; assess impact on product quality and data integrity.
- Risk & Compliance Management: Lead and contribute to risk assessments (GxP, cybersecurity, data privacy); ensure validated state and operational compliance.
- Team Guidance & Mentorship: Advise teams on SOPs, CSV processes, and regulatory standards; foster quality culture and process excellence.
- Audit & Supplier Engagement: Support internal/external audits; lead audit activities for GxP systems; perform supplier assessments.