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