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Primary Packaging Project Lead
Contracting – Brabant Wallon
Primary Packaging Project Lead
Job description
- Primary packaging systems innovation and new products development management :
- New primary packaging systems development management in line with the strategy, “Pipeline Devices & Delivery Systems” and technologic/scientific platforms objectives and according to established working processes.
- Clinical medical devices design and assessment
- Primary packaging systems life cycle & sustaining management :
- Primary packaging systems sustaining and life cycle management coordination and support to all operation sites and CMO’s.
- Competitors pharmaceuticals primary packaging systems benchmarking management :
- Competitors primary packaging systems portfolio analyze & characterization.
- Primary packaging materials, components and technology scouting and assessment according to defined priorities
- Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit
- Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof
- The job holder informs his superior about significant changes and progress without delay on a regular basis and in emergencies.
- Within the unit and/or projects the job holder ensures that the internal regulations and the national laws and ordinances concerning occupational safety, accident prevention, waste removal and disposal, and environmental protection are observed
- In the planning, performance and documentation of his work within the unit the job holder ensures that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed
- The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc
Profile
- Minimum of 5 years working in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage
- Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations
- Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
- Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements
- Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures
- Proven track record in project management / Project Management certification will be a distinct advantage
- Fluency in French & English
Offer
- Company car
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Show emailaddress
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