Warehouse QA Officer

We are looking for a Warehouse QA Officer who is a team player and customer oriented to join our Pharma & Injectable Quality department.

You will work closely with management to ensure the implementation and maintenance of an effective Quality Management System.

• Monitor and adjust Braine warehousing and cold stream operations in order to assure they comply with applicable national and/or international regulations and guidelines (GMP/GDP/21CFR), relevant Quality Policies and Level of Quality requirements.

• Continuously assess the Level of Quality of procedures and practices to identify gaps and opportunities for improvement and simplification

• Support QA and Manufacturing Management to ensure requested Level of Quality within the warehousing areas and cold stream operations

• Pro-actively help operations, identify, develop, and implement quality and operation excellence improvements in response to business requirements, technical changes and regulatory requirements in the relevant scope.

What you’ll do :

Under the responsibility of the Head of QA Dry Forms/Warehouses and in close collaboration with the Cold Chain & Logistic Operations department, you will:

• Ensure alignment with regulatory and cGMP/21 CFR expectations regarding following activities

• Ensure the cold chain and controlled temperature process in order to maintain/ improve the GDP practice.

• Review and approve change controls, failure investigations, deviations, follow-up of complaints, CAPAs, and action plans

• Performing continuous GAP analysis between new expectations and Quality Management System documentation and between UCB documentation and actual practice (update Risk Register regularly)

• Support the preparation, execution, and follow-up of internal and external audits and inspections.

• Handle QA aspects with external customers and partners.

• Assist the Manager in achieving team objectives and act as a backup for other QA Officers as needed.

• Scientific Master’s Degree.

• Minimum of 2 years in a regulated pharmaceutical environment, including at least one year in Quality Assurance (QMS & audit included). Experience with GMP is required.

• Knowledge of worldwide regulations pertaining to cGMP

• Excellent interpersonal and communication skills.

• Strong decision-making skills, accountability, and a delivering attitude.

• Fluency in French and English (written and spoken)

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
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