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QA Associate - Leiden, Netherlands

Eingestellt von Elevate Direct

Gesuchte Skills: Support, Design

Projektbeschreibung

QA Associate - Leiden, Netherlands

The Senior QA Associate provides support for special quality projects and is the process owner for several quality processes. Performs in various quality functional areas and maintains expertise. He/she enforces quality requirements, establishes quality systems for new technologies, reviews development data, approves quality documentation and supports activities related to regulatory submissions and inspections. Uses intrinsic quality to interact with stakeholders and support the site's overall quality level.

Key responsibilities:

Serves as a dedicated quality representative on project teams responsible for design and development of drug products.

Preferably lead auditor for GMP manufacturing for sterile manufacturing and fill finish activities. Serves as the primary quality assurance contact for internal and external business partners and contractors.

Responsible for QA review of vaccines drug substance manufacturing and qualification and validation projects

Focuses on technical issues relative to interpretation of policies, compliance and current industry standard.

Serves a project leadership role as well as assists or participates in special quality projects like the implementation of Intrinsic Quality.

Maintains and interprets KPI's and takes measures to improve.

Effective stake holder management. Contact person for production, analytical and technical global quality initiatives.

Challenges the status-quo. Involved in conception of new ideas with respect to production, analytical and technical quality processes.

Education:

MSc in a relevant discipline, like biomedical sciences, (medical) biology or life sciences

Languages: English, Dutch is recommended

Experience: QA experience, content knowledge, can be a QP Other: Pro-active, agile, and enjoys working in a team. Good organizational and communication skills, creativity, problem-solving capabilities and a process-thinking mindset are key for this position.

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Projektdetails

  • Einsatzort:

    Leiden, Niederlande

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Elevate Direct