Clinical Primary Packaging

il y a 1 semaine

Brainel'Alleud, Wallonie, Belgique Warman O'Brien Temps plein

A Clinical Primary Packaging & Devices Support specialist is required to join a global pharma on a contract basis from
06/19/2023 to 10/31/2023.


The scope is global, covering all PVU, including new chemical and biological entities (NCE and NBE), from a drug product and a device perspective.


MAIN TASKS AND COMPETENCIES:

  • Primary packaging systems innovation and new products development support
  • New primary packaging systems development management in line with strategy, "Pipeline Devices & Delivery Systems" and technologic/scientific platforms objectives and according to established working processes
  • Medical devices used in clinical trials design, selection and assessment
  • Competitors pharmaceuticals primary packaging systems benchmarking
  • Competitors primary packaging systems portfolio analyse & characterization
  • Primary packaging materials, components and technology scouting and assessment according to defined priorities
  • 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/her work within the unit the job holder ensures that the applicable internal rules (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.

PERSON SPECIFICATION:

  • Knowledge of Good Manufacturing Practice and Medical Devices Regulations (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
  • Knowledge in Good Clinical Practices and in devices used in clinical trials
  • 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 experience
  • Experience in evaluating external projects and technologies
  • Experience in intellectual property management
  • HS&E processes and procedures
  • Minimum of 58 years working in the pharmaceutical/biologics/medical device/primary packaging industry. Operational GMP, GCP 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

  • Project Management certification will be a distinct advantage
Please contact me directly for a confidential discussion

Job Types:
Full-time, Temporary contract

Contract length: 4 months

Schedule:

  • Monday to Friday

Work Location:
Hybrid remote in 1420 Braine-l'Alleud

Application Deadline: 05/07/2023

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