Job title: IT Risk and Compliance Analyst – Mauritius
Company: Aspen Pharmacare
Job description: Aspen Global Incorporated (AGI) is the Mauritian subsidiary of Aspen Pharmacare Holdings Limited and was established in 2008. It is a global specialty and branded multinational pharmaceutical company with a presence in both emerging and developed markets.
AGI has been the launchpad of the Group’s Global expansion. We are very proud that from Mauritius we improve the health of patients in more than 150 countries through our high quality, affordable products. Our key business segments are Manufacturing, Supply Chain and Commercial. Our global Brands comprises sterile Focus Brands that include Anaesthetics, Oncology and Thrombosis products. Many of the Aspen supplied medicines are lifesaving or medically critical.
- Over 200 people employed of which 75% are Mauritian.
- One of Mauritius’ largest companies with a turnover in excess of 40 billion Mauritian Rupees.
- Diverse workforce with over 20 different nationalities.
- We are liaising with over 60 different subsidiaries worldwide every day.
- Supplied more than 700 million packs of medicine worldwide since inception.
We are now recruiting for an IT Compliance and Validation Analyst, who will report into the Associate Manager, IT Governance and Compliance.
Overview of Role
This role is in the Governance and Compliance team and is responsible for supporting the IT QSR (Quality System Representative) in defining and managing computer system validation documents, support Business Continuity activities and perform Business Impact Analysis for critical applications. This includes the review and creation of written documentation for computerised systems to meet business and regulatory requirements. The role assists the business integrator for compliance-based IT systems, and also works closely with IT Business Analysts to review requirements, functional specifications and design details of computerised systems.
- Validation and Compliance:
- Collaborate with other IT team members, Quality Officer, and business functions on system validation efforts.
- Apply risk-based approach principles to author and review validation documents supporting GxP computerised systems and relevant infrastructure.
- Assist in computer validation projects to assure compliance with company policies, standard operating procedures, and regulatory requirements.
- Review the execution of testing in support of change control to computerised systems including SOPs, scripts, and reports.
- Review the steps followed for the execution of test scripts and the evidence to ensure proper execution of test scripts.
- Assist Validation Team on validation activities for all IT projects.
- Review IT Validation SDLC deliverables
- Assist the IT business QSR expertise for systems supporting the Quality processes.
- Provide reports and data regarding Change Management activities to the IT QSR, Leadership team and peers on a monthly basis.
- Risk and Compliance:
- Work with the Business Continuity management team to ensure that Disaster Recovery and Business Continuity plans are in place.
- Assist in the development of all testing requirements for a successful Disaster Recovery execution.
- Participate in Business Impact Analysis to help determine system criticality and Recovery Time Objectives (RTOs) for business applications.
- Support the IT Audit process to ensure risks are mitigated in a timely manner.
- Review Incidents, deviations and CAPA
What you will need to be considered
- Bachelor’s or Masters in Life Sciences, Computer Science, Engineering, or similar;
- 3-4 years of work experience in Software Industry in consulting or manual testing role;
- Pharmaceutical industry experience will be an advantage;
- good knowledge of System Development Life Cycle;
- Excellent Manual Testing skills;
- Knowledge of Data Integrity practices is a plus (ALCOA+);
- Knowledge of GxP and GDP practices, 21 CFR Part 11 is an advantage;
- Ability to work in a fast paced international environment and meet deadline.
What’s in it for You?
We have established a reputable business in just over a decade and as we continue to grow we remain committed to your personal & professional development. You will be entering a challenging & rewarding environment and a culture where courage, learning, intrapreneurship, fun and wellbeing are central. AGI is proud to offer a competitive total rewards system that continue to make us a desirable workplace.
Important notice to Employment Businesses/ Agencies
Aspen will not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the Aspen Global Inc. HR department to obtain prior written authorisation before referring any candidates. Obtaining of prior written authorisation is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Aspen Global Inc. In the absence of written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Aspen Global Inc. Aspen Global Inc. therefore shall not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Date posted: Sat, 01 Jul 2023 05:38:46 GMT