Job Description
Graduation in Life Sciences, Pharmacy, Biotechnology, Chemistry, Computer Science, Engineering, or a related discipline. - 9–18 years of total experience, with substantial hands-on exposure to LIMS implementations in regulated environments. - Strong, demonstrable experience in Computer System Validation (CSV) across the full validation lifecycle. - Proven experience working in GxP-compliant environments (e.g., GMP, GLP, GCP) with clear understanding of data integrity principles. - Ability to create and review key validation deliverables (URS, FS, DS, IQ/OQ/PQ, test scripts, traceability matrices). - Experience collaborating with business, QA, and IT stakeholders on system design, testing, and deployment. - Solid communication skills, with the ability to explain complex regulatory and technical concepts to non-technical stakeholders.
LIMS & CSV Solution Leadership - Lead end-to-end implementation, enhancement, and support of LIMS solutions for pharma/biotech clients. - Define and execute Computer System Validation (CSV) strategies, including validation plans, test strategies, and traceability matrices. - Ensure all LIMS and related systems are implemented in alignment with GxP, 21 CFR Part 11, Annex 11, and relevant regulatory expectations. - Conduct impact assessments and risk-based validation for system changes, upgrades, and new deployments. 2. Requirements, Design & Stakeholder Management - Engage with business stakeholders to gather, analyze, and document requirements for laboratory and quality processes. - Translate business needs into functional and technical specifications for LIMS and associated systems. - Facilitate workshops, walkthroughs, and design sessions with cross-functional teams and client SMEs. - Act as primary point of contact for client stakeholders, managing expectations, scope, and priorities. 3. Project & Delivery Management - Plan, track, and manage LIMS/CSV project activities, timelines, and deliverables in line with project management best practices. - Coordinate with internal teams, vendors, and client IT/QA teams to ensure smooth execution and on-time delivery. - Identify project risks and issues, propose mitigation plans, and drive resolution. - Ensure high-quality documentation and adherence to SDLC and validation lifecycle processes. 4. Compliance, Quality & Governance - Establish and maintain validation documentation (URS, FS, DS, IQ/OQ/PQ, SOPs, work instructions). - Support internal and external audits, inspections, and regulatory reviews related to LIMS and computerized systems. - Promote and enforce compliance with GxP, data integrity, and quality standards across project teams. - Drive continuous improvement in validation and compliance practices, templates, and methodologies. 5. Leadership, Mentoring & Best Practices - Mentor and guide junior consultants and team members in LIMS, CSV, and GxP practices. - Contribute to building internal accelerators, frameworks, and reusable assets for LIMS and CSV projects. - Champion knowledge sharing, training sessions, and communities of practice within the organization. - Provide thought leadership on emerging trends in lab informatics, validation, and regulatory expectations.
