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Principal Software Validation Specialist

ValGenesisToronto
On-site Full-time

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Experience Level

Senior

Qualifications

Key Responsibilities:Validation Strategy & Technical Leadership- Serve as the enterprise-level SME for GxP software validation and computerized system validation (CSV/CSA).- Define and oversee validation strategies for enterprise, manufacturing, laboratory, and quality systems, including serialization, labeling, and track-and-trace systems.- Create and uphold validation SOPs, templates, and standards in line with GAMP5 and CSA principles.- Develop scientifically robust, risk-based strategies for equipment cleaning, manual and automated processes, and campaign/product changeover strategies.- Lead validation decision-making for high-risk, novel, or complex systems. Regulatory Compliance & Inspection Readiness- Ensure adherence to global regulations and guidance, including FDA 21 CFR Parts 11, 210, 211, EU GMP Annex 11, ICH Q9 (Quality Risk Management), GAMP 5 (2nd Edition), and FDA CSA guidance.

About the job

Join ValGenesis, a premier provider of digital validation solutions for the life sciences sector. Our innovative suite of products empowers 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, ensure total compliance, and achieve manufacturing excellence throughout the product lifecycle.
Discover what it means to work at ValGenesis, the industry standard for paperless validation in Life Sciences: valgenesis.com/about

We are seeking a Principal Software Validation Subject Matter Expert (SME) to provide strategic leadership in the validation of GxP computerized systems and oversee cleaning validation programs across our pharmaceutical manufacturing operations. This pivotal role ensures that our systems are validated and maintained in accordance with FDA, EMA, and global regulatory requirements, utilizing risk-based, lifecycle-driven methodologies aligned with GAMP 5 and FDA CSA guidance.

About ValGenesis

ValGenesis stands at the forefront of digital validation for the life sciences industry, providing innovative solutions that streamline compliance and enhance manufacturing processes. Our commitment to excellence has made us a trusted partner for leading pharmaceutical and biotech firms worldwide.

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