Quality Graduate

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.

We employ over 200 people of which 75% are Mauritian.

We are one of Mauritius' largest companies with a turnover in excess of 40 billion Mauritian Rupees.

We have a diverse workforce with over 20 different nationalities.

We are liaising with over 60 different subsidiaries worldwide every day.

We have supplied more than 700 million packs of medicine worldwide since inception.

Overall Job Objectives

This role is in the Quality Team at Aspen Global Incorporated (AGI).

This resource person will report to the Quality Associate Manager and will be mainly responsible for ensuring the compliance of products supplied to the markets with the registered details, preparing documents to sites and supporting Junior Quality Associates/Quality Associates / Quality Managers in the administrative tasks to manage manufacturing site(s) with respect to quality related activities (e.g. handle deviations, customer complaints, change controls and keep documentation from sites) ensuring that site operates following Good Manufacturing Practices (GMP) requirements.

Responsibilities

Ensure compliance of products supplied to the markets with the registered details

Liaise with the Regulatory Team/Affiliates to confirm the registered details of the product in the market (e.g. shelf-life, storage condition, specification, etc.) and prepare product compliance documents with this information in a timely manner

Monitor the regulatory approvals and communicate to manufacturing site.

Monitor the required qualification status of the suppliers by maintaining up to date relevant documentation including technical agreements, product quality reviews, stability reports, quality statements and trackers

Maintain up to date relevant documentation including technical agreements/PRS, product quality reviews, stability reports, quality statements and Excel trackers;

Support Junior Quality Associates/Quality Associates / Quality Managers to manage manufacturing site(s) on quality related activities

Support on customer complaints with the manufacturing sites/ affiliates/ distributors.

Handle change controls/requests from manufacturing sites, logging on the system and monitoring the completion of the tasks.

Handle the deviations raised by manufacturing sites, logging on the system.

Review documents from manufacturing site and maintain the relevant tracker (e.g. Product quality reviews, stability data, etc.).

Liaise with the manufacturing site(s) for all quality-related items/issues and monitor CAPA completion related to Aspen audits.

Assist during the internal /external audits /Inspections

Enhance AGI’s Quality Management system identifying and implement process improvement.

Support in Quality/ compliance projects