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Quality assurance manager manufacturing unit monoclonal antibodies

Basel
Coopers Group GmbH
EUR 73’984.8 pro Jahr
Inserat online seit: 27 Oktober
Beschreibung

Overview

Contract start date: As soon as possible

Contract end date: September 2026

Location: Basel


Responsibilities

Responsibilities:

* Central contact person for purchasing, QC and production companies in all quality issues, for raw material approval and qualification.
* Ensuring quality oversight and GMP compliance for the raw materials and projects served.
* Review, assess and approve specifications, both on paper and in SAP/SLIMs
* Responsibility for the release of direct materials
* Process, assess, and approve deviations, corrective actions (CAPAs), and technical change requests.
* Self-inspections and support internal audits and authority inspections.
* Active contribution of ideas for the continuous improvement of processes and support in the implementation of them.


Qualifications

Requirements:

* Completed university degree in a scientific or engineering field (e.g. biology, chemistry, pharmacy, biotechnology)
* Experienced in dealing with common IT systems in the pharmaceutical industry
* Min. 1 year of professional experience in the field of Quality Assurance or GMP Compliance, or 3 years in a GMP regulated working environment
* Strong team player with excellent communication skills
* High quality awareness and an independent, result-oriented and assertive way of working
* Fluent communication in German and English (spoken and written)
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