Advanced Software Engr

A QMS Validation Specialist in the Life Sciences industry is responsible for ensuring that Quality Management System (QMS) software operates accurately, securely, and in compliance with strict regulatory standards. They bridge the gap between IT solutions and Quality Assurance (QA).

Qualifications

Key Technical Qualifications

• Education: Bachelor’s degree in Life Sciences, Biotechnology, Computer Science, or Engineering.
• Software Platforms: Familiarity with modern enterprise QMS platforms like TrackWise Digital, Veeva Vault Quality, MasterControl or ValGenesis.
• Validation Frameworks: Deep practical knowledge of GAMP 5, data integrity principles, and electronic signatures regulations.

Soft Skills

• Strong analytical and technical writing capabilities.
• The ability to translate complex IT and quality concepts into understandable terms for cross-functional stakeholders.
• High attention to detail with an ability to manage multiple validation projects simultaneously.

Responsibilities

Core Responsibilities

• Validation Documentation: Create, review, and execute validation lifecycle documents, including Validation Plans (VP), User Requirement Specifications (URS), Functional Requirements Specifications, Traceability Matrices (RTM), and Test cases for IQ/OQ/PQ.
• Regulatory Compliance: Ensure QMS systems align with global life science regulations like FDA 21 CFR Part 11 (electronic records and signatures), EU Annex 11, and GAMP 5 guidelines for software validation.
• Risk Management: Conduct risk assessments (e.g., FMEA) to identify and mitigate compliance or data integrity gaps.
• Change Control & CAPA: Manage software changes, deviations, and Corrective and Preventive Actions (CAPA).
• Training & SOPs: Develop training materials and Standard Operating Procedures (SOPs) to ensure end-users utilize the QMS software securely and compliantly.
• Audit Support: Act as the Subject Matter Expert (SME) during internal audits and external regulatory inspections regarding the QMS implementation.