RESPONSIBILITIES

The main activities of this function will be:
  • Source data from batch records, lab books, data management systems and existing reports, evaluating the information, and generate summary reports.
  • Author device and delivery systems development protocols, reports, risk assessment and templates.
  • Manage documents within systems.
  • Data mine from physical and electronic repositories.
  • Verify data integrity for all relevant documentation.
  • Manage, analyze and visualize data, and documentation arborescence.
  • Generate training materials based on lessons learned exercises.
  • Present/discuss documentation in project team meetings,
  • Assess in project team the timelines and deliverables and coordinate and track the relevant documentation accordingly.
  • Liaise with other departments or external partners to ensure documentation meets stakeholder’s needs (quality, regulatory, commercial manufacturing, etc…).

PROFILE AND EXPERIENCE

  • Minimum of 3 years working in the pharmaceutical/biologics/medical industry.
  • Operational GMP or quality experience would be a distinct advantage.
  • Practical understanding of Good Manufacturing Practice and ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements.
  • Ability to collaborate in the context of cross-functional internal and external project teams.

SKILLS

  • Comfortable working with CRMs (customer relationship management)
  • Sense of organization and priority management
  • Project management skills in planning, tracking.
  • Relational skills / communication skills
  • Excellent planning and organizational skills.
  • Technical writing experience in English.
  • Understanding of HS&E processes and procedures.

Publish Date

19 April, 2023

Spontaneous Application

Technical Documentation Lead- Medical Devices 877

New opportunities open up across PLG all the time. If nothing matches right now, send us a spontaneous application: we will keep you in mind for what comes next.

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