We are currently looking for aCompliance/IT consultantto support one of our clients, pharmaceutical laboratory.
Responsibilities
- General Activities:
- Contribute to the development and implementation of strategies for Veeva Vault Tools (RIM and PromoMats).
- Ensure the activities of Business Administrator for ARM in accordance with the current processes and GxP computerized systems regulations.
- Collaborate continuously with contributors and other stakeholders.
- Develop and maintain quality standards and good practices with users.
- Conduct technology/regulatory watch to maintain the adequacy of the specificities and performances of the databases to the needs of the users.
- User Support:
- Provide user support and incident resolution in accordance with current administrative processes and regulations.
- Offer support and expertise on technical topics for projects related to the activities.
- Manage issues (functional requests, incidents) in collaboration with contributors, including collection, impact analysis, solution proposals, and implementation.
- Participate in the implementation of releases and manage interfaces with contributors and Veeva on technical topics.
- Change Control Management:
- Create, update, and maintain schedules for change controls.
- Coordinate commissioning activities from drafting requirements to implementation in accordance with change management instructions.
- Manage progress meetings and ensure compliance with deadlines.
- Training and Documentation:
- Develop and execute tests, provide impact assessments, and give approval prior to production.
- Contribute to updating technical documentation.
- Prepare user training support and organize meetings with users to monitor the implementation.
Profile
- Bachelor’s Degree in Computer Science, Information Technology, or a related field.
- 5+ years of experience in IT Compliance, Audits, and/or IT Risk Management.
- Proven experience with Veeva Vault RIM and PromoMats systems.
- Strong knowledge of GxP computerized systems regulations.
- Experience in managing change controls and coordinating implementation activities.
- Excellent communication and collaboration skills.
- Ability to work independently and manage multiple tasks effectively.
- Both French and English required.
Preferred Qualifications:
- Experience with VSI (Validation of Systems and Instruments).
- Knowledge of regulatory requirements including Sarbanes-Oxley, Data Privacy regulations, and GxP Validation requirements.
- Familiarity with NIST Framework, CCPA, PIPL, and GDPR.