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  • Location

    Breda

  • Job title:

    Senior Quality Assurance

  • Sector:

    Biotechnology

  • Job ref:

    48791

  • Start Date:

    2022-07-26

Quality Assurance (GMP)

The Company

Our client is one of the worlds biotechnology companies, value-based, looking for innovation to transform the lives of patients with severe illness.

Role Description     

As a Quality Assurance you will be responsible for handling complaints (including conducting assessments) in accordance with internal procedures, regulatory guidelines and business performance objectives.

Responsibilities

Initiate and own product quality complaints.
Safety quality investigations and product security investigations.
Perform assessments in support of complaint investigations
Partner with corporate product quality surveillance, assessors from other Amgen sites and contracted partners to resolve product complaint investigations
Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements.
Initiate and own QA Non Conformances/CAPAs as needed
Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required.

Requirements
Bachelor’s/ Master’s degree or equivalent.
Experience with Pharmaceutical Industry.

Experienced within Quality Assurance/ Quality Associate


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