Senior QA Associate
SIRE
Zuid-Holland, The Netherlands
1 dag geleden

The company

Our client is a professional organisation, based in Zuid-Holland Netherlands. They are committed to developing first-in-

class or best-in-class vaccines for some of the world’s most life-threatening infectious diseases. They partner with many of the world’s leading experts, academic and clinical institutions and other pharmaceutical companies for the development of vaccines against, for example, Ebola and HIV.

At this company, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.

Role description

The Senior QA Associate assures compliance with regulatory requirements and internal company procedures via appropriate oversight and planning, conducting, and reporting quality inspections, report audits, internal and external facility evaluations, system audits, and data reviews that support company late stage development projects.

Furthermore, the Senior QA Associate supports release activities.

Responsibilities

  • Supplier management including auditing, monitoring and maintenance of Quality agreements suppliers including external manufacturing, laboratories, GMP services and GMP raw material suppliers
  • QA oversight of validation, qualification activities connected to drug substance and drug product manufacturing.
  • Assesses compliance with regulations for late stage development matters.
  • Participates in regulatory agency inspections, (global) project team meetings, and training activities.
  • Communicates effectively with professional staff and leadership across departments.
  • Effective stakeholder manager, able to influence. The go-to’ person on difficult content issues.
  • Challenges the status-quo. Involved in conception of new ideas with respect to improvement of business processes or procedures.
  • Leads the execution of systems aimed at evaluating and maintaining quality and compliance.
  • Complies to EHS and GMP-standards and has solid company credo awareness acting accordingly
  • Drafts, revises, reviews and contributes quality assurance guidelines to research and development standard operating procedures.
  • Leads process improvements and contributes to the ongoing development of new procedures, techniques and departmental guidelines.
  • Requirements

  • Minimally MSc in a relevant discipline, like Pharmacy or Bio-Pharmaceutical Sciences
  • Minimal 5 years of relevant experience in Quality Assurance in the (bio-)pharmaceutical industry
  • Other information

    You can submit your application until the 11th of July.

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Seppe Verhoeven.

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