Offer summary

Qualifications:

Must be located in the region, ideally French speaking, Education to degree level required, Minimum 1 year experience in CSV required, knowledge of GAMP5 and QALM.

Key responsabilities:

Create and update documents according to procedures

Participate in project test executions and KPI creation for compliance monitoring

Attend weekly review meetings with IT Compliance Lead

Job description

CSV Consultant (Junior) - Contract 8 Months euro 300 per day

Essential:

Candidates will only be considered who already located in the region, French speaking would be an added bonus, must have a full comprehension of writing and spoken English.

 This a hybrid role with 2 days onsite / 3 days remote.

Job Description

We are looking for a CSV expert who is proactive, motivated & autonomous to join our Compliance team based in Belgium.

What youll do

· Creation of all document in Source CD based on the Source CD procedures and on the validation approach (deliverable list) approved by the IT Compliance Lead

Periodic Review Execution: collect reports required by the periodic review exercise; Test execution in QALM, preparation of report, creation and follow up of Defect, Deviations and CAPA
Support Medior/Senior to Review project test execution review in QALM
Create / Update IT Validation template.
Support team on KPI creation, compliance monitoring like training assignment, deviation follow up etc.

· Be part of a weekly activities review meeting with associated IT Compliance Lead

Who youll work with

· You will have a direct report to the IT Compliance Lead on personal activities via biweekly meeting.