Quality Assurance Specialist (mfd) – Clinical Supply & QP Support

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) you will play an important role in supporting our Qualified Persons (QPs) throughout the certification and release process for clinical trial materials. Working in a highly regulated GMP/GDP environment you will help ensure that all required documentation is complete compliant and available for timely batch certification.

This role offers a unique combination of quality assurance documentation management and cross-functional collaboration allowing you to work closely with international customers project teams and internal stakeholders while contributing directly to patient safety and regulatory compliance.

A Day in the Life

As part of our Quality Assurance team you will help ensure that clinical trial materials are released accurately compliantly and on schedule.

Your responsibilities include:

• Preparing reviewing and compiling documentation required for QP certification and batch release
• Coordinating with customers Global Project Managers and internal teams to obtain and track quality documentation
• Preparing Certificates of Release Confirmations of Import and QP Declarations
• Verifying country-specific clinical trial approvals and maintaining release documentation
• Supporting the creation review and maintenance of SOPs and other quality documents
• Maintaining QP tracking tools documentation records and compliant archiving practices
• Supporting internal audits client audits and health authority inspections
• Participating in investigations CAPA activities and quality system improvements
• Contributing to Permanent Process Improvement (PPI) initiatives and helping optimize QA processes
• Youll work in close collaboration with cross-functional teams and play an important role in ensuring that clinical trial supplies meet the highest quality and regulatory standards before reaching patients around the world.

Keys to Success

Education:

• Completed vocational training as PTA PKA CTA Pharmaceutical Assistant or a comparable qualification

Experience:

• Quality Assurance or Quality Control within the pharmaceutical industry
• Experience working in a GMP-regulated environment
• Previous exposure to documentation management batch release or clinical supply operations is an advantage

Knowledge Skills Abilities

• Good understanding of GMP/GDP requirements and pharmaceutical quality systems
• Structured detail-oriented and quality-focused approach to work
• Strong organizational and documentation skills
• Customer-oriented mindset with excellent communication skills
• Proficiency in Microsoft Office; experience with SharePoint TrackWise or eDMS is beneficial
• Ability to work independently as well as collaboratively within cross-functional teams
• Fluent German and good English communication skills (written and spoken)

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

This position offers the opportunity to contribute directly to the quality and compliance of clinical trial supplies while working closely with Qualified Persons global project teams and international customers. If you enjoy structured work thrive in a regulated environment and want to make a meaningful impact on patients worldwide wed love to hear from you.

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.