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Project Manager Quality - On/of site support South-Africa

Employer
NonStop Consulting
Location
South Africa
Salary
Negotiable
Closing date
Nov 29, 2020

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Sector
Pharmaceutical, Quality Assurance
Contract Type
Contract/Freelance
Hours
Full Time
Organization Type
Corporate

Job Details

For my client, one of the biggest companies in the world, we are looking for a Quality Project Manger that has experience in vaccines and has knowledge about technology transfer! This is a great opportunity where you can help produce vaccines that are in high need. This is a project that lasts 6-12 month and where on/off site support is needed in South Africa. Travelling there will be necessary but you will not need to stay there during the whole project.

Responsibilities

Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the EM sites and associated off-site storage locations; Support site qualification activities and development of quality agreements in accordance with company standards; Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure products/processes comply with cGMP requirements; Support regulatory submission activities, and lead inspection readiness activities in partnership with EM site and JJRC to support global health authority approvals; Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CPA management, escalation of critical issues, and change control; Monitor EM quality performance and proactively identify risks and mitigation plans through bench-marking and knowledge sharing: Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence; Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc) to meet patient supply requirements; Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

What we are looking for:

  • Bachelor's Degree with a focus on engineering, science, or an equivalent technical discipline;
  • Minimum of 8 years working in an FDA regulated environment;
  • Experience in pharmaceutical aseptic manufacturing operations and quality assurance;
  • Detailed knowledge of cGMPs related to pharmaceutical production;
  • Experience in Vaccine Production/ QA
  • Experience in Technology Transfer
  • Experience working with External Manufacturers or Labs
  • Ability to quickly process complex information and make critical decisions with limited information required

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!

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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