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  • Location

    Leiden

  • Job title:

    Quality Control Specialist

  • Sector:

    Pharmaceutical

  • Job ref:

    49158

  • Start Date:

    2022-09-19

Quality Control Specialist

Our client is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden, hard-working and multi-scaled people are working in a high-performance culture in which innovation and a 'can do' state of mind are the central points.

Role Description

As a Technical Specialist will actively handle the Medium and High quality and compliance issues at the lab independently or with help of the lab technicians. Will work to maintain cGMP compliance and LEAN status of the team. Act as Subject Matter Expert (SME) during cGMP inspections and is SPOC (Single point of contact) for the lab during new product implementations, investigations, qualifications, etc.

Responsibilities

- Responsible for deviation management, acting as lead investigator for non-conformances and coordinator of appropriate corrective/preventive actions.

- Creates, reviews and updates lab documentation and NPI supporting documents.

- Provides technical support to the lab, input in services group and cooperates with local/global key stakeholders.

- Acts as a technical system owner for (analytical) equipment.

- Acting as Subject Matter Expert during audits and inspections.

- Role model to safety, compliance, and reliability

Requirements

  • Bachelor’s degree (HLO) or higher education in Life Sciences, molecular biology or comparable
  • -5 years’ experience with microbiology techniques; Bioburden, Endotoxin, Sterility and Speciation testing.
  • GMP experience is a plus

Other information:

Are you interested and want to apply for role, feel free to contact me.