Compliance/IT consultant - VAF271

Groupe ProductLife; France; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A pharmaceutical consulting firm in Auvergne-Rhône-Alpes is seeking a Compliance/IT consultant. Responsibilities include supporting Veeva Vault Tools, managing change controls, and providing user support. Candidates should have a Bachelor's degree in IT, at least 5 years of experience in IT compliance, and excellent communication skills in both French and English. The position offers a chance to engage in various IT compliance activities within the pharma sector.

Qualifications

• 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.

Responsabilités

• Contribute to strategies for Veeva Vault Tools.
• Manage change control activities.
• Provide user support and incident resolution.

Connaissances

IT Compliance

Auditing

Risk Management

Communication

Collaboration

Formation

Bachelor’s Degree in Computer Science or IT

Outils

Veeva Vault RIM

PromoMats

Description du poste

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.