Quality Assurance Specialist

vor 1 Monat


Kaiseraugst, Aargau, Schweiz Solvias AG Vollzeit
Quality Assurance ManagerJob Summary

At Solvias AG, we are seeking an experienced Quality Assurance Manager to join our team. In this role, you will be responsible for ensuring the highest standards of quality and compliance within our organization.

Responsibilities

* Review and approval of SOP's, protocols, reports, Certificate of Analysis, and other quality documents
* Support quality investigation of deviations and Out of Specification (OOS)
* Maintenance, recording, and processing of corrective and preventive measures (CAPA)
* Performing internal audits
* Organization and management of customer audits, and inspections
* Apply and interpret audit and compliance requirements
* Act as QA point of contact for customers
* Support for GMP training

Requirements

* Scientific education (Master degree) in analytical chemistry/biochemistry/life science
* Multi-year, industrial work experience of 7 years minimum in the analytical-pharmaceutical environment preferably experience in QA
* Strong problem-solving skills to meet business objectives
* Excellent interpersonal skills and teamwork spirit
* Ability to collaborate in a dynamic, cross-functional matrix environment
* Broad knowledge and proven experience of the regulatory framework in the GMP environment (ICH, FDA, USP, Ph. Eur.)
* Solid background in data integrity and computerized systems risk assessment and project support
* Experience as an auditor is an asset
* Fluency in English and willingness to learn German is required

What We Offer

* Flexible work models such as part-time and remote work
* Minimum 28.5 vacation days
* Monthly child allowance above the Swiss minimum
* Voluntary monthly family allowance
* Various pension fund solutions
* Daily allowance insurance and non-occupational accident fees paid by Solvias
* Reka cheques
* Commuter contribution for using public transport
* Employee discount programs for fitness, insurance, retail, and more
* Onsite canteen

If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application.

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