Senior IT Business Analyst
hace 4 semanas
Senior IT Business Analyst - eDMS and QMS
Job Description:Galderma is a leading dermatology company with a presence in over 90 countries. We are seeking a Senior IT Business Analyst with expertise in electronic Document Management Systems (eDMS) and Quality Management Systems (QMS) to join our team.
Key Responsibilities:- Collaborate with business stakeholders to gather, analyze, and document functional and technical requirements for eDMS and QMS systems.
- Translate business needs related to document lifecycle management, quality control, and compliance into clear, actionable IT specifications.
- Lead or support the implementation of eDMS and QMS solutions, ensuring alignment with business goals, industry standards, and regulatory requirements.
- Ensure all eDMS and QMS systems meet regulatory standards such as GxP, ISO, and 21 CFR Part 11.
- Lead system validation activities, including user acceptance testing (UAT) and creation of validation documentation.
- Facilitate workshops, meetings, and presentations to align stakeholders on project goals, timelines, and system capabilities.
- Analyze and document current document management and quality control processes, identifying areas for improvement.
- Recommend and implement process changes leveraging eDMS and QMS solutions to enhance productivity, compliance, and audit readiness.
- Proven experience as an IT Business Analyst specializing in eDMS and QMS within regulated industries (pharmaceutical, biotech, medical devices).
- Strong understanding of regulatory requirements such as GxP, ISO, and 21 CFR Part 11.
- Experience with system validation and process optimization in document and quality management.
- Excellent communication, stakeholder management, and problem-solving skills.
- Experience with the implementation or maintenance of eDMS/QMS platforms (e.g., OpenText, Veeva Vault, MasterControl, Sparta TrackWise).
Galderma offers a dynamic and challenging work environment with opportunities for professional growth and development. We are committed to empowering our employees and promoting their personal growth while ensuring business needs are met.
How to Apply:Please submit your application, including your resume and cover letter, to [insert contact information].
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