Job Description :
We are seeking a CSV Analyst - GXP Compliance to ensure the governance, development, and maintenance of Digital Platforms and Engineering Software Development Cycles are compliant with ISO 9001 : 2015, ISO 27001 : 2013, GxP, and corporate guidelines.
The position will drive quality and velocity improvements, administer and maintain the QMS, ISMS, and GxP compliance, and support audit and compliance efforts across the organization.
The role will also provide strategic support to Agile teams and shared services areas, with a focus on ensuring compliance in all aspects of the development Responsibilities :
- Implement, upgrade, and support the software development cycle while ensuring compliance with ISO 9001 : 2015, ISO 27001 : 2013, GxP, and corporate guidelines.
- Provide strategic and technical guidance on compliance scope and standards across the organization.
- Perform internal audits and document audit activities, ensuring timely follow-up and closure of audit findings.
- Maintain audit schedules, track progress, and report on audit outcomes to leadership.
- Work closely with Agile Teams and Shared Services Areas to ensure compliance requirements
are met across all departments.
Coordinate with teams and leaders to ensure audit findings are resolved and compliancestandards are maintained.
Develop a coherent data strategy to support business decision-making and drive the DigitalPlatforms and Engineering team towards a fully data-driven approach.
Analyze collated data and provide actionable insights to improve software development processes.Document processes, maintain audit files, and ensure periodic reviews of applicable data sources and documentation.Conduct training sessions and workshops for teams to ensure adherence to compliance standards and foster a compliance-focused :7+ years of relevant experience in compliance or audit roles.Lead / Internal Auditor certification for ISO 9001 : 2015 and ISO 27001 : 2013.Bachelor's or Master's degree in Business Administration, Engineering, or a related field.Proficiency in Microsoft Office Suite.Strong communication skills, with fluency in oral and written English.Ability to manage multiple projects, work independently, and meet deadlines.Strong organizational, analytical, and time management skills.Agile Certifications (e.g., Scrum, Agile, SAFe).2+ years of experience with Atlassian tools (JIRA, Confluence).4 - 5+ years of experience in ISO and GxP audit.Experience in conducting training sessions and workshops for compliance activities.Strong analytical and organizational skills with great attention to detail.Excellent time management skills to handle competing priorities.Effective communication skills to build and maintain relationships at all levels.Ability to work in a fast-paced environment while maintaining confidentiality.Self-starter with the ability to take ownership and drive initiativesref : hirist.tech)