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Ausy

QA Batch Review and Sample Tracking

  • Ausy
  • Antwerp
  • Permanent, Full-time
Published on Jobat.be 12 days ago

QA Batch Review and Sample Tracking

Do you want to support External Quality as a QA Specialist/Generalist from a QA & Compliance point of view in the oversight of pharmaceutical third-party manufacturing operations in Europe and South Africa? Apply here!

Do you believe in affordable healthcare? Are quality & safety your priority number 1? Then you'll feel comfortable in this company, who's one of the biggest pharmaceutical companies in the world.

You definitely need to apply if you're looking for a contract at AUSY, a project based contract or an opportunity as a freelancer, because it's all possible! Just get in contact with me: laurence.teerlynck@cx.ausy.be or call 03 369 19 80.

This function is 100% remote.

Job description

This role will support External Quality as a QA Specialist/Generalist from a QA & Compliance point of view in the oversight of pharmaceutical third-party manufacturing operations in Europe and South Africa. 

  • Review batch documentation provided by contract manufacturers (CMO) and responsible for product release
  • Ensure all required testing and documentation are provided and met release requirements
  • Manage/Track OMCL/CBER samples from CMO to final shipment to government facility
  • Generate OMCL/CBER protocols for lot release
  • Alert supervision of any nonconforming results, out of trend, or out of specification results
  • Support supply chain logistics for on time shipment from CMO to Warehouse

Profile

  • Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline
  • Minimum of 4 years working in a Health Authority regulated environment
  • Experience in quality assurance; experience in pharmaceutical aseptic manufacturing operations is a plus
  • Detailed knowledge of cGMPs related to pharmaceutical production
  • Must have strong ability to maintain high efficiencies and accuracy in data entry
  • Ability to quickly process complex information and make critical deciscions with limited information at times
  • Excellent knowledge of English

Offer

As an answer to your high performance & flexibility, AUSY offers you an interesting salary package, with some interesting extras like:

  • Meal vouchers of €7
  • Net representation cost of €50
  • Hospitalization insurance
  • Car + unlimited fuel card OR home-work compensation
  • 32 holidays
  • End-of-year bonus
  • Pension plan
  • ECO vouchers
  • Opportunities to follow trainings

And on top of this you'll improve your skills and become an even bigger expert!

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    48 days left to apply

    Characteristics

    Requirements

    • Secondary education

    Offer

    • Permanent
    • Full-time

    Apply before

    • 18 April

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