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PRODUCTIE SUPERVISOR Vroege/late ploeg

Only 6 days left

QA Analyst

  • Benefits
    • Group insurance
    • Company car
    • Petrol card
    • Meal vouchers
    • Laptop
    • Family hospital insurance
6 days ago

Senior Quality Specialist

  • Benefits
    • Group insurance
    • Company car
    • Petrol card
    • Meal vouchers
    • Laptop
    • Family hospital insurance
Only 6 days left
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Jefferson Wells

Senior Quality Specialist

Permanent, Independent, Full-time
6 days left to apply

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.?

Let's look together at your first challenge with us!

Senior Quality Specialist

Job description

Scope of work:

As a Quality Specialist you act as the day-to-day liaison with internal and external customers for quality related activities.

  • Ensure GMP compliance of products manufactured and/or tested at a contract facility.
  • Ensure all aspects of product manufacturing and/or testing are reviewed versus established quality standards and the applicable marketing authorizations.
  • Manage quality systems, e.g. change control, deviations, complaints, and product investigations.
  • Modify, review, and ensure contractor quality standards and protocols for processing materials into partially finished or finished product meet Sanofi and GMP requirements.
  • Contribute to the completion of milestones associated with specific projects.

 

 

Responsibilities:

 

Release product in accordance with approved specifications and procedures.

  • Monitor contractor compliance via GxP documentation review and on-site visits/audits.
  • Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
  • Compile data and write summaries for periodic product reviews, investigations, complaints, and deviations.
  • Distribute applicable contractor documentation for Regulatory, Validation, and Subject Matter Expert review.
  • Interact with multi-functional internal and external project teams to ensure compliance.
  • Respond to technical and quality issues and handle schedule and/or process-related conflicts.
  • Demonstrate understanding of applicable US and global regulations related to manufacture of medicinal products (small molecules and biologics).
  • Monitor contractor performance to established Key Performance Indicators (KPI) and report adverse trends.
  • Provide guidance to less experienced staff, as applicable.

Profile

Who are you?

  • Bachelor or Master degree and 3-5 years of experience in a cGxP or other regulated environment, to include 3+ years in a Quality role
  • Excellent communication and organizational skills.
  • Demonstrated ability to perform work requiring attention to detail and of high quality (i.e. right first time).

You have to stay in Scotland for 3-4 weeks followed by +/- 6 weeks back in homeoffice and followed again by 3-4 weeks in Scotland. This would be for the whole assignment.

Offer

  • Group insurance
  • Company car
  • Petrol card
  • Meal vouchers
  • Laptop
  • Family hospital insurance

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.?

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To : Jefferson Wells | Diegem 1831

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Function type:
Location
Requirements
Professional bachelor (Higher Education Short Type) English