Recruitment Fraud Alert
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If you believe you have been contacted by an unauthorized person, please contact your local law enforcement agency immediately.
Quality Systems Sr Specialist
Primary duties :
Act as Lessines’ Execution Lead for Quality Systems : mainly Deviation management
- Ensure the deployment, implementation and maintenance of the activities related to Quality Systems for the Lessines facility, mainly Deviation Management system
- Ensure and maintain compliance with current regulations/requirements of quality systems.
Conduct gap analyses of local Quality systems in accordance with the global Quality Systems procedures and regulations, define and implement actions
- Monitor the Quality Systems to ensure compliance with the Global procedures and regulations and evaluate additional need for training/coarching of the users.
- Interface with quality, manufacturing or other groups to promote adherence to the deviation process, identify improvement actions and follow up on the implementation of these actions.
- Define, review and analyze Quality Systems’ metrics. Define appropriate actions to maintain satisfactory metrics
- Collaborate with the Lessines Quality Systems team members and the Takeda organization to align and improve the management of the Quality Systems.
- Support inspections conducted by Health Authorities, Customers, and License Partners
- Active participation to the Annual Product Quality Review process providing data’s and conclusions
- Communicate with owners, QA disposition, supply chain and any impacted department to ensure disposition of lots impacted by a deviation.
Education and Experience Requirements
- Bachelor’s – Master’s degree in engineering, chemistry, biology or related discipline
- At least 3 years’ experience in Quality or related field in the pharmaceutical industry.
- Understanding of pharmaceutical quality management systems and regulations including current GMPs & GDDPs.
Key Skills, Abilities, and Competencies
- Fluent in French, professionnal level of English
- Critical thinking, analytical and problem solving skills.
- Demonstrated ability to work autonomously
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
- Strong organizational skills
- PC skills and be competent in Word, Excel, PowerPoint and Trackwise