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Protocol Intelligence
Data-driven signals on your job's competitivenessPhilips brand and Bangalore location increase applicant density despite niche CSV specialization.
Role demands regulated-medical-device CSV/CSA expertise and inspection experience, limiting cross-industry transferability.
Requires explicit 8–12 years, regulated CSV/CSA experience, and audit readiness, so filters are strict.
Job Description
Structured overview of role & requirementsAbout This Role
Own and strengthen the validation and assurance framework for non-product software and computerized systems in regulated medical device environments.
Lead quality oversight across the full computerized system lifecycle including planning, risk assessment, validation deliverables, change control, and audit readiness.
Drive improvements in validation efficiency and inspection readiness while maintaining compliance, and coach/mentor team members on lifecycle and assurance requirements.
Minimum Requirements
8-12+ years experience in computerized systems, software quality, validation, or quality assurance within regulated life sciences including medical devices, pharmaceutical, or biotechnology.
Bachelor’s or master’s degree in engineering, computer science, information systems, life sciences, quality, or related technical field (or equivalent experience).
Hands-on experience in planning, authoring, executing, reviewing, and approving Computer System Validation (CSV) or Computer Software Assurance (CSA) deliverables for complex systems.
Experience supporting audits and inspections related to computerized systems and validation strategies.
Ideal Candidate Profile
Experienced in applying risk-based validation, data integrity, electronic records/signatures, supplier assurance, and maintaining validated systems in regulated environments.
Comfortable influencing across matrix organizations and translating regulatory and quality requirements into practical controls for diverse teams including IT, Quality, and Regulatory.
Knowledgeable about FDA QSR, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, GAMP 5, and modern delivery models like Agile, DevOps, cloud/SaaS platforms.