Quality Assurance Specialist (mfd) Pharma

Work Schedule

Environmental Conditions

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving complex analytical challenges increasing productivity in their laboratories improving patient health through diagnostics or the development and manufacture of life-changing therapies we are here to support them. Our global team of more than 100000 colleagues delivers an unrivaled combination of innovative technologies purchasing convenience and pharmaceutical services through our industry-leading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD.

Location/Division Specific Information

Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.
You can find out more about our location in Weil am Rhein and Rheinfelden here:

Discover impactful Work

As a Quality Assurance Specialist (m/f/d) at Thermo Fisher Scientific you play a critical role in ensuring compliance quality and operational excellence within a regulated GMP/GDP environment. You support quality systems documentation control and secondary packaging quality oversight contributing directly to patient safety regulatory compliance and a strong quality culture across the site.

A Day in the Life

• Perform maintenance quality review and approval of TrackWise Quality Records including Investigations CAPAs and Change Controls
• Ensure deviations and quality events are fully documented in compliance with GMP/GDP requirements
• Support root cause analyses and conduct effectiveness checks for CAPAs
• Manage scheduling coordination and communication for documentation reviews and approvals
• Provide QA-related input to support project timelines and production planning
• Maintain accurate complete and audit-ready QA documentation
• Oversee execution of QC activities in Secondary Packaging including Start-Up checks In-Process Controls and Final Release
• Coordinate with QC Team Leads when operational QC tasks are delegated
• Ensure GMP/GDP compliance across all secondary packaging quality processes
• Support and participate in self-inspections client audits and regulatory authority inspections
• Conduct and support QA Gemba walks
• Review update and maintain SOPs
• Analyse report and track quality metrics to support continuous improvement initiatives
• Proactively identify and escalate quality risks and propose mitigation actions to the Line Manager

Keys to Success
Education:

• Completed vocational training as PTA MTA CTA or a comparable qualification
• Alternatively a scientific background with relevant pharmaceutical experience

Experience:

• Experience in the pharmaceutical industry preferably in GMP QA or QC
• Experience within packaging and distribution environments is highly desirable
• Solid GxP knowledge gained through training or practical experience
• Experience in root cause analysis and investigation report writing is an advantage

Knowledge Skills Abilities

• Strong understanding of EU GMP requirements
• Proven ability to work in a structured detail-oriented and compliant manner
• Proficiency in Microsoft Word Excel TrackWise and electronic document management systems (eDMS)
• Strong written and verbal communication skills and confidence working with cross-functional stakeholders
• Excellent organisational and administrative skills
• Fluency in German and English (B2 level or higher written and spoken)
• Strong team player with a proactive and quality-focused mindset

What we offer

• Employment with an innovative future-oriented organization
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity intensity involvement and innovation

If you are interested please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific each one of our 100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin disability or any other legally protected status.

Apply today!

Agency notice!
Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.