Global QMS Business Administrator (Durban North) at Aspen Pharma Group

Job Purpose:

• The Global Business Administrator is responsible for system functionality, user requirements, and configuration specifications, plus identification of impacts on other products within the Veeva Quality Suite. Provide system and administration support to business users within the organization. This role is a 2nd-line support, acting as a bridge and channel between Local Business Admins, Super Users, and Technology Enabled Shared Services (TESS). 

Key Performance Areas:

Veeva Quality and Qdocs Governance

• Develop, maintain, and train Group Polices, SOPs, training material, and Guidance Documents related to the two systems.
• Support to onboarding new sites/ affiliates as per agreed timelines.
• Together with the Business process owner, ensure a validated state of the system from a business perspective

Veeva Quality implementation

• Support the implementation of Veeva Quality applications by fully participating in the workshops.

Change Management

• Support Veeva-related changes to ensure the success (on time) of General releases & User requested changes.
• Collaborate with TESS/Veeva on the impact assessment of auto-on features and admin checkbox of General releases, and on user-requested changes to ensure smooth running of the systems.
• Participate in the assessment of the configurable features and user-requested changes with Local Super Users and drive the implementation of the features that will bring value, benefits to Aspen and follow the GxP requirements.
• Support the business process owner on the overview of the status of changes related to Veeva RIMS & QDocs via scheduled meetings with the business.

Continuous Improvement

• Together with the business process owner, develop and lead a Continuous improvement team with Super users to identify and drive process improvements in QA & Regulatory to streamline the activities, establish efficient ways of working, address any identified gaps, and share the knowledge/learnings.
• Ongoing Training of Aspen Users on the system and guiding the queries.
• Participate in Veeva-related events/trainings, to understand the new upcoming features and for Improvements to be made to the system.

Requirements
Educational Qualifications and Experience:

• Bachelor's or Postgraduate degree in Quality Management, Chemistry, Pharmacy, or equivalent degree (Science degree).
• Veeva Business Admin training (Quality) is an added advantage.
• Certification in other GMP systems (e.g., TrackWise) is an advantage
• A minimum of 2 years of experience working with Veeva QMS and Veeva QDocs in a similar role.
• 3 - 5 years of Pharmaceutical or related industry experience within Quality Assurance.
• Business administration experience with the Veeva QMS and Veeva QDocs, e.g., Management of picklists, templates, creating reports, & dashboards, etc.
• Knowledge of Quality business processes, such as change control and CAPAs.
• Ability to translate business requirements to technical aspects of the system.
• Ability to effectively communicate with various levels of business stakeholders, i.e., SMEs, Quality Managers, and technical representatives.
• Ability to support the analysis, design, and implementation of system process improvement changes.

Skills and Attributes:

• Ability to work in a multicultural, international, and dynamic environment. 
• Global Thinking
• Risk management.
• Ability to work autonomously.
• Stakeholder management
• Strong Written Communication Skills
• Risk management.
• Teamwork & Cooperation
• Presentation skills
• Advanced knowledge of QMS processes and Document Management
• Knowledge of GxP requirements
• Intermediate to advanced Microsoft Office proficiency (Excel, Word, PowerPoint).
• Experience and knowledge of regulatory business processes/Veeva RIMS are an advantage.