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Quality Assurance Specialist - Pharma(m/w/x)
Hosting client audits and participating in health authority inspections for pharmaceutical products. GMP/GDP QA experience required. Company pension scheme, outstanding career prospects.
Requirements
- Academic degree in technical field (pharmacy, natural science, engineering) or PTA/MTA/CTA (or equivalent)
- Experience in pharmaceutical industry, preferably GMP QA or QC
- Experience in packaging and distribution environments highly desirable
- Solid GxP knowledge (training or practical experience)
- GMP/GDP QA experience
- Audit and inspection experience preferred
- Strong understanding of EU GMP requirements
- Structured, detail-oriented, compliant manner of working
- Proficiency in Microsoft Word, Excel, TrackWise, eDMS
- Strong written/verbal communication, confidence with cross-functional stakeholders
- Excellent organisational and administrative skills
- German and English fluency (B2 or higher, written and spoken)
- Strong team player, proactive and quality-focused mindset
Tasks
- Schedule and host client audits
- Participate in health authority inspections
- Complete client audit responses on time
- Plan and perform internal audits
- Detect compliance issues
- Complete Quality Assurance approval of investigations
- Conduct initial quality review of investigations
- Assign investigations to appropriate personnel
- Approve CAPAs
- Participate in Permanent Process Improvement activities
- Support quality systems
- Control documentation
- Oversee secondary packaging quality
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Excel
- TrackWise
- eDMS
Benefits
Career Advancement
- Outstanding career and development prospects
Retirement Plans
- Company pension scheme
Informal Culture
- Exciting company culture
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Quality Assurance Specialist - Pharma(m/w/x)
Hosting client audits and participating in health authority inspections for pharmaceutical products. GMP/GDP QA experience required. Company pension scheme, outstanding career prospects.
Requirements
- Academic degree in technical field (pharmacy, natural science, engineering) or PTA/MTA/CTA (or equivalent)
- Experience in pharmaceutical industry, preferably GMP QA or QC
- Experience in packaging and distribution environments highly desirable
- Solid GxP knowledge (training or practical experience)
- GMP/GDP QA experience
- Audit and inspection experience preferred
- Strong understanding of EU GMP requirements
- Structured, detail-oriented, compliant manner of working
- Proficiency in Microsoft Word, Excel, TrackWise, eDMS
- Strong written/verbal communication, confidence with cross-functional stakeholders
- Excellent organisational and administrative skills
- German and English fluency (B2 or higher, written and spoken)
- Strong team player, proactive and quality-focused mindset
Tasks
- Schedule and host client audits
- Participate in health authority inspections
- Complete client audit responses on time
- Plan and perform internal audits
- Detect compliance issues
- Complete Quality Assurance approval of investigations
- Conduct initial quality review of investigations
- Assign investigations to appropriate personnel
- Approve CAPAs
- Participate in Permanent Process Improvement activities
- Support quality systems
- Control documentation
- Oversee secondary packaging quality
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- Microsoft Word
- Excel
- TrackWise
- eDMS
Benefits
Career Advancement
- Outstanding career and development prospects
Retirement Plans
- Company pension scheme
Informal Culture
- Exciting company culture
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Thermo Fisher Scientific
Industry
Pharmaceuticals
Description
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
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