Global Quality Lead Support

il y a 3 semaines

Brainel'Alleud, Belgique Jefferson Wells Temps plein

Location:
**Braine L'Alleud**
**#23107**

**Global Quality Lead Support**
Brabant Wallon - contracting

Our partner is looking for a **Global Quality Lead Support** to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.

**What are your responsibilities?**

This position provides support to a Global Quality Lead relative to Quality Assurance activities associated with the lifecycle management for a product transitioning from Development to Commercial by:

- Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.
- Maintenance and lifecycle management of QA product flows
- Audits and Inspection anticipation and readiness
- Review of Annual Stability Plan
- SOPs and other control documents writing, review and approval as needed
- Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
- Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
- Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
- Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed

**Who are you ?**
- You already worked in GMP environment for 5 years
- You are experienced in operating across cultures and in a multi-cultural environment
- You have experience in GMP audits and inspections would be an advantage
- You are Fluent in French and your English is not bad

**What can you expect ?**
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

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