Katalyst HealthCares and Life Sciences

Compensation

Full Description

Responsibilities: - • Validation Planning & Execution: - Develop, review, and execute validation protocols (DQ, IQ, OQ, PQ) for laboratory instruments and computerized systems. • Support integration, regression, and performance testing of software and equipment. • Participate in validation execution in GxP-regulated facilities. • Documentation & Compliance: - Prepare and maintain validation life cycle documentation including URS, FRS, Risk Assessments, Traceability Matrix, SOPs, and Validation Summary Reports. • Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, and GAMP 5 guidelines. • Contribute to periodic reviews and revalidation processes for laboratory systems. • Risk Management & CAPA: - Conduct risk assessments and gap analyses to identify potential issues. • ssist in deviation investigations and support Corrective and Preventive Actions (CAPA) implementation. • Collaboration & Continuous Improvement: - Work closely with Quality Assurance, R&D, Production, and IT teams to deliver validation deliverables. • Collaborate with hardware/software development teams on troubleshooting and debugging activities. • Recommend process improvements and contribute to updates of SOPs and validation practices. Requirements: - • Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, or related discipline required. • Master's degree or professional certifications in Computer System Validation (CSV), GAMP 5, or Regulatory Compliance preferred. • 06 - 09 years of experience in laboratory instruments and software validation within clinical research, pharmaceutical, or biotechnology environment. • 03 - 05 years of specialized experience in the following areas: - • Validation of analytical instrument systems (e.g., spectroscopy, chromatography, protein analysers, PCR systems, sequencers). • Equipment qualification (DQ, IQ, OQ, PQ). • Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5. • Validation documentation authoring (Validation Plans, URS/FRS, Risk Assessments, Traceability Matrix, Validation Reports). • Risk management and CAPA support for validated systems. • Strong technical writing, analytical, and communication skills. • bility to work in global, cross-functional team environments and deliver on multiple projects concurrently. • We are seeking a Lab Instruments Software Validation Analyst with 06 - 09 years of progressive experience in the clinical research, pharmaceutical, or biotechnology industry. • The successful candidate will be responsible for ensuring the reliability, accuracy, and regulatory compliance of laboratory instruments and software systems used in clinical trials. • This role requires a strong technical background in validation methodologies, regulatory compliance, and equipment qualification, along with the ability to collaborate effectively with cross-functional teams. • The candidate should bring at least 03 - 05 years of focused, hands-on expertise in specialized validation skill areas.