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QA Compliance Validation Consultant

Eingestellt von Harvey Nash IT Recruitment Belgium

Gesuchte Skills: Consultant

Projektbeschreibung

One of our clients, a multinational pharmaceutical company, currently requires a QA Compliance Validation Consultant

Start date: February 2014
Duration: 6 months, renewable
Location: South of Brussels

Job Purpose

- Ensure QA Validation Periodic Review activities for NPI
- Take the responsibility for QA in Validation
- Assure regulatory inspection readiness (L2 - L3/L4)

Key Responsibilities

- Review and approve the system periodic review
- Ensure the compliance in validation activities
- Approve the validation documentation regarding the GMP requirements and the GSKBio procedures: Periodic Review - Validation master plan
- Approbation of risk assessment
- Ensure timely escalation to Mgt of critical issues during Periodic Review exercise
- Review and approve the potential CAPA plan issued from Periodic Review
- Perform internal audit (L2) of validation activities
- Ensure implementation of validation related commitments towards internal/external inspections
- Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process

Education

- University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)

Knowledge

- Good interpersonal relationship skills
- Good oral and written communication skills in French & English
- Problem solving and achievement oriented

Previous Experience

- At least 5 years of experience in Prod., Valid. or QA in a biopharmaceutical industry
- Experience in auditing techniques

Projektdetails

  • Einsatzort:

    Brussel, Belgien

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Organisation/Management

  • Skills:

    consultant

Harvey Nash IT Recruitment Belgium