Artwork Compliance Associate
Aspen
Mauritius, ZA
6d ago

Description

Aspen Global Inc. 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.

A few other interesting facts about us are :

  • We supply more than 150 countries around the world
  • We have supplied more 500 million packs of medicine worldwide
  • We employ over 225 people in Mauritius
  • We have over 24 nationalities speaking 20 languages working in our offices
  • We have closed more than 20 global deals since inception in 2008
  • We are the international holding company for more than 60 subsidiaries
  • Our portfolio compromises of over 100 products and 5000 trademarks
  • We manage more than 3500 SKUs, from 60 Manufacturing sites and 25 active pharmaceutical ingredient (API) manufacturers.
  • We are now recruiting for an Artwork Compliance Associate reporting to the Associate Manager Compliance.

    Overview of Role

    This role is in the Compliance Team within the Pharmaceutical Affairs Department (Which consists of Compliance, Quality and Regulatory teams) at Aspen Global Incorporated (AGI)

    You will be mainly responsible for managing manufacturing site(s) with refers to artwork compliance activities with support from Associate Manager Compliance and non-

    direct support from the Associate Manager Artwork (e.g. confirming site artwork change implementation, change controls, enhancing technical agreements and keep documentation from sites) ensuring that site operates following Good Manufacturing Practices (GMP) requirements and ensuring compliance of products supplied to the markets with the registered details.

    Also the Compliance Associate will support to coach other Junior Compliance Associates.

    Duties and Tasks

  • Manage the artwork implementation at manufacturing site(s) and artwork compliance related activities (with support from the Associate Manager Compliance when required)
  • Liaise with the manufacturing sites (finished product) and packing sites for all artwork compliance related items (change controls, artwork implementation, risk manufacture and repacking).
  • Develop and enhance ways of working and processes with manufacturing sites through emails and periodic teleconferences as applicable.
  • Interface between manufacturing site and distributor / affiliates / other AGI streams for artwork compliance related items (e.
  • g. site evidence of artwork change implementation, repacking protocols and recertification of product).

  • Coordinate artwork implementation change controls with the manufacturing sites and provide responses to the complainant / contact person.
  • Assess the deviations raised by manufacturing sites relating to artwork, evaluating the impact on the registered details, the supply continuity as well as the investigation from manufacturing site.
  • Negotiation of the Technical Agreement between AGI and manufacturing sites to document the responsibilities with respect to the artwork compliance requirements.
  • Review documents from manufacturing site (e.g. packing validation protocols & validation report, repacking protocols, etc.).
  • Ensure compliance of products supplied to the markets with the registered details
  • Liaise with the Regulatory Team / Affiliates to confirm the artwork implementation timelines of the product in the market (e.
  • g. livery changes, QP implementation dates, specification, etc.) and prepare / obtain documents with this information (Site declaration).

  • Monitor the regulatory approvals and communicate to manufacturing site.
  • Guide Junior Compliance and Artwork Associate(s) on daily activities to be performed, providing technical knowledge and ensuring the completion in a time manner.
  • Develop the Junior Compliance and Artwork Associate(s) with respect to the technical knowledge and AGI processes.
  • Seek for process improvement in the Compliance team.
  • Enhance AGI’s Quality Management system identifying and implement process improvement.
  • Requirements

    What you will need to be considered

  • Quality, Project Management or equivalent degree
  • 3 to 5 years’ experience in a pharmaceutical industry. Preferably within the Quality or Artwork department (however experience from the production environment will also be considered).
  • Understanding of artwork implementation regulations for various markets, especially highly regulated markets such as Europe
  • Effective negotiation of agreements such as Quality Technical Agreements
  • Attention to detail and high work efficiency
  • Effectively works under pressure and prioritization of tasks
  • Apply
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