Compliance & Quality Systems Manager

il y a 1 semaine

Brainel'Alleud, Belgique Jefferson Wells Temps plein

Location:
**Braine l'Alleud**
**#23695**

**Compliance & Quality Systems Manager**:
Braine-l'Alleud - Contracting

**What do we expect from you?**:
Accountable/ responsible for ensuring the facilities is compliant with regulations and the standard quality systems in place, in collaboration with the owners of each individual area, which includes:

- Access, confined areas and material and people flows through the facilities
- Pest control management for the building (periodic visit and non conformity management)
- Environmental monitoring (viable and non-viable) of the GMP areas and utilities, being the SPOC for the GMP manufacturing area and representative in the EM periodic meeting, managing asssessment of non conformities with stakeholders, suggesting actions and follow up with SMEs, reviewing/generating the periodic trending, keeping an eye on an optimal cleaning of the facilities.
- Unexpected facility/environment event management (quick status, decision, quick actions plan and coordination with all the SMEs)
- Risk management
- Gowning process
- Training of people on standard processes related to facilities and general quality systems
- Highlight and prepare key topics and issues at Quality meetings
- Quality standards/regulations Gap analysis, risk and remediation plans management
- Monthly Quality Lead Team meeting preparation and Lead
- GMP training annual refresh for the Pilot Plant: collaboration on the content
- Deviations and Change Controls management linked to all the listed systems, general quality topics
- Continuous improvement management linked to all the listed systems, general quality topics
- Minimum Bachelor’s degree in sciences with min. 10 years experience in a regulated pharmaceutical area is required
- Experience in production or quality, dealing with quality systems is required
- Excellent understanding in GMP related environment
- Experience with environmental monitoring is required
- Experience in Biopharmaceutical is an asset
- Experience dealing with Deviations and Change Controls
- Foster lean and efficient processes, by continously challenging status-quo and striving for improvements

**What can we offer you?**:
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).

**Do you want to know the rest of the recruitment process?**

If this sounds like you and you're keen to find out more, I urge you to apply

Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly

We can't wait to meet you, so don't wait any longer

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