Veeva Vault QMS Business Administrator
Il y a 2 mois
Our partner is looking for a Veeva Vault QMS Business Administrator to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. Job description
- work with the process owners and core business leads to streamline legacy quality processes using Veeva functionality and drive user efficiency.
- work with the business to develop and document system & user requirements (process, data & reporting)
- participate in configuration testing in different system environments (sandbox, development, and acceptance)
- participate in the authoring of computerized system validation documentation
- participate in user manuals and training material creation/revision
- support Go live cutover plan
- support users during hypercare period
- support migration activities (from previous QMS system)
- support change management and communication to SMEs and user community
- Minimum Level of Education Required - Bachelor’s Degree
- Preferred Level of Education - Veeva Certification
- Area of Specialization - Veeva Vault/Vault Quality Suite/ QMS
- 5 or more years of experience in administration or maintenance of Quality Management System (preferably in the biosciences or pharmaceutical industry).
- Proficiency in GxP Pharmaceutical Regulations (EMA, FDA, ICH), including those specific to computerized systems.
- Good knowledge of validation requirements for computerized systems in the pharmaceutical environment.
- 2+ year of Veeva Vault Quality Experience and particularly desirable is QMS experience
- Proven experience in working in cross-functional projects.
- Strong process improvement skills and orientation
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