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Gmp compliance specialist

TieTalent
EUR 30’000 - EUR 80’000 pro Jahr
Inserat online seit: 5 Juni
Beschreibung

Join a world-class manufacturing team at the forefront of biotech innovation. If you're passionate about GMP compliance and quality excellence, this is your opportunity to make a real impact in a fast-paced, high-growth environment.

About the Client

Our client is a well-established leader in the life sciences sector, operating a state-of-the-art facility in Switzerland. The company plays a critical role in large-scale biomanufacturing, supporting global clients across the pharmaceutical, biotechnology, and chemical industries. With a strong focus on operational excellence and regulatory compliance, they offer a collaborative and fast-paced environment for professionals passionate about quality and innovation.

Job Description

This position is ideal for professionals with experience in GMP environments who are passionate about maintaining high compliance standards in regulated manufacturing operations. The role focuses on supporting quality systems such as deviation investigations, CAPAs, and change controls, while ensuring timely and accurate documentation. Working closely with cross-functional teams, the successful candidate will play a key role in driving quality culture, audit readiness, and continuous improvement. This is a hands-on, on-site role in a dynamic and evolving production environment.

Responsibilities

* Manage and support investigations related to deviations, non-conformances, and quality issues
* Define and oversee CAPAs to address root causes and drive long-term solutions
* Ensure compliance with GMP and regulatory standards across operational areas
* Collaborate with manufacturing, quality, engineering, and other teams to support quality initiatives
* Participate in audits and inspections as a subject matter expert on GMP deliverables
* Support and improve documentation workflows related to quality systems
* Maintain audit readiness and contribute to continuous improvement of quality processes
* Utilize digital systems (e.g., TrackWise) to manage quality-related records and tasks

Requirements

* Degree in Life Sciences, Engineering, or related scientific discipline
* Experience working in a GMP-regulated environment within biotech, pharma, food, or chemical sectors
* Strong understanding of deviation management, root cause analysis, and CAPA processes
* Familiarity with digital quality systems such as TrackWise or equivalent
* Ability to manage multiple priorities while ensuring documentation accuracy and compliance
* Excellent problem-solving, communication, and collaboration skills
* English fluency required; German is a plus but not essential
* Experience in large-scale or commercial manufacturing is an advantage
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