Fresh Jobs 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.

Aspen Competencies:

Business:

• Foster Consumer and Customer Commitment
• Performance Driven
• Accountability/ Ownership

People:

• Communicate EffectivelyLead and Influence Others

Self:

• Continuously Grow and DevelopContribute Special Expertise

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Job Purpose:

• This role will support the implementation and monitoring of the Group Quality Management System, ensuring compliance with regulatory requirements and pharmaceutical best practices.
• Maintain Group Quality policies and procedures and provide training to all Aspen Affiliates.
• Develop and manage Group Quality Awareness programs to ensure or improve Affiliates’ compliance status.

Key Performance Areas:

Group Quality Governance

• Develop and maintain Group Quality policies and procedures aligned with the regulatory GMP requirements and minimum Group Standards and provide training to all Aspen Affiliates.
• Define the minimum QMS standards required at the Aspen affiliate via Group Policies or Guidance.
• Develop and manage Group Quality Awareness programs to ensure or improve Affiliates’ compliance status.
• Establish KPIs to monitor Aspen Affiliates' QMS.

Monitoring and Continuous Improvement

• Manage and monitor the Group Audit Program for Aspen Affiliate. Manage the Aspen Affiliates Audit Schedule and liaise closely with GOQC to ensure that Aspen Affiliates are audited according to the schedule.
• Inform GOQC if the need for a cause audit arises and what the timeframe is.
• Provide pre-audit documentation to the auditor.
• Monitor and work with the Aspen Affiliates to close the CAPA records related to the audit findings.
• Maintain the Working Practice between Group Compliance and GOQC, defining the requirements and responsibilities for audit for Aspen Affiliates.
• Monitor the implementation and compliance with GQMS standards across all regional affiliates as well as Holdings' core functions, ensuring that each Affiliate Marketing Authorisation Holding (MAH) entity, defined non-MA holding entity, and those that provide essential support to the Aspen MAH.

Implementation of QMS at APHL           

• Implement and enhance the overall QMS in APHL.
• Roll-out of QMS for key departments with a direct impact on Group Products and the management thereof.
• Maintenance of Standard Operating Procedures (SOPs) following the defined structure, review of SOPs from other departments
• Ensure that training requirements relating to APHL SOPs are included in the training plans of the relevant departments.
• Manage the GMP process in APHL, Durban, e.g., change controls, deviations, CAPA, self-inspection.
• Established processes in compliance with GMP requirements.
• Develop and enhance ways of working and processes within APHL.
• Monitor APHL QMS through KPIs.

System SME

• Support the implementation of the Digital Quality System

Requirements
Qualifications and Experience:

• Bachelor's or Postgraduate degree in Quality Management, Chemistry, Pharmacy, or equivalent degree (Science degree).
• GMP or ISO 9001 certification will be advantageous
• A minimum of 3 years of pharmaceutical industry experience within Quality Assurance
• Proven track record providing support in a similar function.
• Pharmaceutical industry experience (preferably within an international context)
• Demonstrated experience and understanding of GMP requirements.
• Implementation of Quality Management System (QMS)
• Ability to effectively communicate with various levels of business stakeholders, i.e., SMEs, Quality Managers, and technical representatives.
• Experience in document management.
• Experience in working within Digital Quality Systems.

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
• Knowledge and application of Good Manufacturing Practices (GMP)
• Document management and quality systems (e.g. Veeva, TrackWise)
• Intermediate to Advanced Microsoft Office proficiency (Excel, Word, and PowerPoint)
• Auditing experience is advantageous.

Aspen Competencies:

Business:

• Foster Consumer and Customer CommitmentPerformance DrivenAccountability/ Ownership

People:

• Communicate Effectively
• Lead and Influence Others

Self:

• Continuously Grow and Develop
• Contribute Special Expertise