Quality Assurance Specialist (m/f/d) Pharma

Quality Assurance Specialist (m/f/d) Pharma

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.

Work Schedule and Environmental Conditions

Standard Office Hours (40/wk)

Office environment

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

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 organizational 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

EEO Statement

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