The purpose of this job is to act as quality expert for quality/compliance related topics in relation with the Packaging, Visual inspection and Labelling operations.
The function will also support CI and digital initiatives through the Packaging, Visual inspection and Labelling department.
Quality Operation within his area of responsibility (Packaging and Labelling):
• Assure the correct deployment of the cGMP, Takeda guidance within the quality operations department
• Represent quality in significant quality-related issues, provide support and expertise. Understanding technical/production complex problems and evaluating potential impact on product quality
• Participate in the definition of the quality requirements for projects related to e.g. process/facility/Equipment modification
• Support any quality decision on the floor in coordination with Manufacturing.
• Review data trending in QA perspective within his frame of responsibility ( for example Visual inspection meeting monitoring)
Quality system within his area of responsibility:
• Act as quality representative in the evaluation, the implementation and the approval of change control
Act as Quality Representative in the evaluation (risk evaluation, mitigations, lots potentially impacted and to be held from release), the investigation (including quality impact) and the approval of deviation Reports
• Lead, support and/or participate to continuous improvement initiatives
• Act as a Yellow Belt coach for projects within the department
• Lead and/or support digital initiatives
• Support all global initiatives related to quality related topics for the area of responsibility
• Provide expertise during the revision of Global procedures and guidances
• Participate in external inspections.
• Provide support if necessary to the Regulatory team by providing required data for submission files
Master degree in Sciences (Chemist, Bioingeneer, Bio statiticien, Pharmacist, …)
5-10years Experience in GMP environment and manufacturing environme nt
Excellent IT and digital system knowledge/capability
Critical thinking, stress resistant, autonomy,
Ability to summaries information, technical writing skills,
strong communication skills,
knowledge in risk management regulation, data analytics skills
ability to work in a matrix organization
Driven by operational excellence and digital solutions
Focusing on priorities, handle multiple topics simultaneously in a high-volume environment, while meeting deadlines and attention to details
Ability to work effectively with all levels of management and resolve problems in a timely manner
French and English (written and spoken – advanced level) – manadatory