ESIQ Specialist (QA)

NonStop Consulting Limited | Posted 5-11-2020

South Africa ()


This is a great opportunity in which you can help produce COVID-19 vaccines that are in high need. This is a project that lasts 6-12 months within a permanent contract and where on/of site support is needed in South Africa for this project. Travelling there will be necessary but you will not need to stay there during the whole project.

You will be part of a team with the main goal to reach the successful delivery of a Knowledge Based flawless technical transfer of DS and DP to the CMO in South-Africa that our client utilizes to produce their COVID19 vaccine. The External Supply Integration Quality (ESIQ) is a Global Quality organizational unit of our clients Supply Chain which provides leadership and owns Quality and Compliance oversight on suppliers and external manufacturers who supply either material for my client its drug products or manufacture finished drug products for my client.

We are looking for a Quality Specialist who will manage from a QA & Compliance point of view the pharmaceutical third party manufacturing operations in this project.

Responsibilities

  • Maintain or build partnership with the QA counterparts of External Manufacturer and with the other External Manufacturing stakeholders within the company (such as PES - Partnership & External Supply - GTS - Global Technical Services - Compliance, Regulatory, L&A, Logistics).
  • Assure that the manufacturing operations for the company at the External Manufacturers run smoothly from a QA point of view and in a compliant way. Assists in the development, implementation and review of standard operating procedures for interactions with contract manufacturers.
  • Pro-actively identify risks and potential issues and delays and where possible resolving them. Makes proposals and assists in the development of corrective action plans and monitors implementation. Follows up on closure of corrective and preventive actions.
  • Ensure that all relevant QA related concerns of the External Manufacturing Organisation are raised at the relevant levels within the company.
  • Prepares for and facilitates audits and inspections.
  • Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time. Provides quality support for technology transfer and improvement of existing manufacturing processes.

What we are looking for:

  • Bachelor\'\'s or Master\'\'s degree in either life science discipline, e.g. Chemistry, Pharmacy, Microbiology or Engineering
  • Minimum 6 years of experience in Quality or Operations departments
  • Able to work virtually connecting with other sites, customers and global functions
  • Ability to influence and interact at multiple levels of the organization
  • Strong ability to manage problems and urgencies during issue management
  • Ability to manage multiple priorities and deliver excellent results
  • Excellent written and verbal communications skills (In English)

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via S.Thijs@nonstopconsulting.com. You can contact me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!