Job Description: We are seeking a Validation Lead / Test Lead with strong experience in Life Sciences and Manufacturing domains, especially with POMS MES systems and integration testing. The ideal candidate should have a solid understanding of CSV, CSA, and GxP processes, with a proven track record of leading validation and testing teams in pharmaceutical or life sciences projects.
Responsibilities: - Lead validation and testing teams across onshore/offshore environments for Life Sciences projects.
- Manage customer and stakeholder communication directly, ensuring project alignment and quality delivery.
- Drive and implement Computer System Validation (CSV) and Computer Software Assurance (CSA) practices in compliance with regulatory standards.
- Oversee POMS MES and integration testing within manufacturing and supply chain systems.
- Create and maintain best practices, guidelines, and checklists for GxP-compliant project execution.
- Ensure timely delivery of validation deliverables including test plans, protocols, reports, and traceability matrices.
- Utilize tools like JIRA, Confluence, Micro Focus ALM (Client ALM), and MS Office for project management and tracking.
Requirements: - 15+ years as Validation Lead and 5+ years as Test Lead with hands-on validation/test execution.
- 5+ years hands-on experience in POMS MES and integration testing.
- 4+ years' experience in Manufacturing/Supply Chain projects.
- 2+ years in Life Sciences domain (Pharma/Biotech preferred).
- Strong expertise in CSV, CSA, and GxP processes.
- Experience managing global teams and customer relationships.
- Excellent communication, coordination, and leadership skills.
