Aspen Global is the Mauritian subsidiary of Aspen Pharmacare Holdings (Aspen), the world’s fifth largest supplier of branded and generic pharmaceutical products. Aspen is the largest pharmaceutical company listed on the South African stock exchange as well as one of the top 20 companies listed on this exchange. We are responsible for sourcing and managing more than 3,500 stock keeping units from over 75 manufacturing sites around the world and supplying to more than 150 countries internationally. Since its inception Aspen Global has supplied 200 million packs of medicine worldwide and currently manages more than 6,000 orders and supplies 85 million packs annually.
The backbone of Aspen Global’s business, and one of the reasons for its success, is the talented pool of people comprising more than 210 staff members across nine departments.
Aspen Global is a proud equal opportunity employer with >50% of the headcount comprising females and more than 20 different nationalities represented.
As part of our continued growth, we are now recruiting for a Projects & Compliance Analyst
When you start the role you will be a key member of the Projects & Compliance team which is part of the IT department.
You will be responsible for defining and managing computer system validation documents and activities for key IT systems, and acts as a link from global to regional offices. This includes the review and creation of written documentation for computerised systems to meet business and regulatory requirements.
You would act as IT business integrator for the compliance-based IT systems, and also works closely with IT Business Analysts to review requirements, functional specifications and design details of computerised systems.
- You will collaborate with other IT team members, Quality Officer and business functions on system validation efforts and the improvement of existing IT Quality processes/practices.
- You will apply risk based approach principles to author and review validation documents supporting GxP computerised systems and relevant infrastructure.
- You will provide oversight of computer validation projects to assure compliance with company policies, standard operating procedures and regulatory requirements.
- Oversee the execution of testing in support of change control to computerised systems including SOPs, scripts and reports.
- Work with regional teams to ensure global validation strategy is understood and followed.
- Provide IT business integrator expertise for systems supporting the Quality processes.
- Support the IT Audit process to ensure risks are mitigated in a timely manner.
What you will need to be considered
- Pharmaceutical industry experience.
- 3+ years of quality management experience in validation of computerised systems of varying complexity.
- Knowledgeable in the computerised systems regulations of the US and EU (21 CFR Part 11 & Validation).
- Good understanding of life cycle development and implementation processes.
- Familiar with risk based approach concepts and application to validation strategies and activities.
- Bachelor’s degree or certification in computer science or information systems related area with computerised systems and validation or equivalent experience.Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.
Help us knowing more about you by including a cover letter with your application to clearly describe how you meet the competencies for this role.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.