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Quality Operations Specialist
il y a 3 semaines
F or the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - NPI.
The key tasks are :
Operations:
Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and in Cleaning activities, including:Review and approval of the documentation linked to quality agreements, process optimization & validation, analytical, operations and cleaning documentation to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirementsManagement and approval of change controls, CAPAs & deviations and participation in on-line problem solving with other departmentsRelease of API batches:
GMP and Quality Work with counterparts from Strasbourg and other sites to establish common (best) practices in quality related systems, policies and procedures Recommend changes in practices to enhance the conformance to GMP within all departments Perform internal and external audits as required Hygiene, Safety and Environment In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations. People management and team spiritExperience in People Management
Plan and prioritize the activities of the direct reports to minimize the production disturbance, meet the planning objectives as well as the Quality and Regulatory expectations. Ensure that the required and continuing training of the direct reports is carried out and adapted according to needs Motivate, listen to and manage the direct reports, maintaining a sound work spirit and manage relationship problems Implement "empowerment" and "full management" ways of life throughout the organization Evaluate annually the direct reportsInformation/Communication:
Be the point of contact for customers quality topics (audits, customers requests, complaints and recalls) Inform management in case of any major quality or people management problem Make personnel aware of the importance of safety, environmental and GMP issuesWhat we expect from you is :
Master in Sciences with minimum 5 year experience in QA in a GMP Environment & NPIFluency in French and English is mandatory (spoken and written English) Excellent command of Word, Excel and PowerPoint High organizational skills , good interpersonal skills, flexibility in tasks and schedules Sense of responsibility , enthusiasm, diplomacy and team spirit
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Quality Operations Specialist
il y a 1 semaine
Braine-l'Alleud, Wallonie, Belgique PolyPeptide Temps pleinF or the Quality Assurance Department of our Belgian site located in Braine-l'Alleud, we currently have an opening for an experienced Quality Operations Specialist - Commercial. The key tasks are (among others): As a QA referent for products, the major accountabilities includes to Be the quality point of contact for customers and participate in the...
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Braine-l'Alleud, Wallonie, Belgique PolyPeptide Temps pleinF or the Quality Assurance Department of our Belgian site located in Braine-l'Alleud, we currently have an opening for an experienced Quality Operations Specialist - NPI. The key tasks are : Operations: Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and in Cleaning activities,...
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