Introduction
Experis, part of the ManpowerGroup, is a global market leader in HR services and talent sourcing solutions.
Present in over 50 countries worldwide, our clients are amongst the most prestigious companies in today’s changing world of work.
Experis-experts provide top candidates with challenging missions in the specialties IT, Engineering, Life Sciences , Finance and Human Resources
Your career is our mission !
Organization
For a client located in the province of Hainaut leader in the pharmaceutical industry, we are looking for QA Specialists.
Function
The main aim of this mission is to ensure the compliance of data identified to be included in the PAS. Therefore, the mission as QA Consultant is to perform thorough data check of GMP documents and remediated any gap according to Quality System. You will provide to owners package for inspection readiness purpose.
– Ensure QA oversight in validation and production activities (IQOQ / PQ / PV, Batch records…) by performing thorough data check of GMP documents regarding the GMP requirements and the procedures
– Ensure that quality issues or potential compliance risks are captured, followed up and treated through deviation and CAPA Quality Systems
– Prepare inspection readiness package to give overview on specific topics, deviations, changes…
– Support the production, QA and technical service teams in the implementation of CAPA Globalization and continuous improvement plan
– Ensure that production practice are aligned with validation conclusion
– Manage quality trend analysis, quality reviews on the system
– Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
Requirements
Required Experience & Knowledge
– University degree in Science
– Experience in FDA environment requested
– Former relevant industrial experience or equivalent in pharmaceutical Prod., Valid. or QA in a biopharmaceutical.
– Relevant experience in GMP, CFR, Eudralex
– A previous experience in a QA department is a real asset.
Soft skills:
– Analytical review of GMP documents
– Problem solving and achievement oriented
– Good interpersonal relationship skills
– Team spirit
– Fluent in French and good knowledge in English
Offer
We offer you an attractive salary as well as an attractive salary package with possibility of a company car. You’ll also work in a dynamic environment with great challenge. [cx_apply_button]
