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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
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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