Quality Assurance Specialist (m/f/d) Pharma
As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.
Quality Assurance Specialist (m/f/d) Pharma
Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Office
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 100,000 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: www.fisherclinicalservices.com
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
- Schedule and host client audits
- Participation in health authority inspections
- Complete client audit responses on time
- Plan and perform internal audits to detect compliance issues
- Complete Quality Assurance approval of investigations
- Complete initial quality review of investigations and assign to appropriate investigators
- Complete other QA activities as requested to support the business
- Approve CAPAs
- Participation in Permanent Process Improvement (PPI) activities
Keys to Success
Education:
- Academic degree in a technical field such as pharmacy, natural science, engineering or PTA/MTA/CTA (or equivalent)
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
- GMP/GDP QA experience
- Audit and inspection experience, preferred
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
