PCI Pharma Services Germany GmbH
Quality Assurance Specialist(m/w/x)
Full-timeOn-siteExperienced
Großbeeren
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PCPCI GER PCI Pharma Services Germany GmbH
Quality Control Specialist(m/w/x)
Großbeeren
Full-timeOn-siteExperienced
Nejo AI Summary
Incoming, interim, and final inspections of clinical trial samples, with GMP document preparation. Pharmaceutical quality control experience required. On-site work in a 500+ employee pharmaceutical services provider.
Requirements
- Apprenticeship as PTA, PKA, CTA, or Bachelor's in Pharma
- First professional experience in pharmaceutical quality control
- Very good knowledge of GMP/GDP regulatory requirements
- Good knowledge of deviations, CAPAs, and change control
- Good knowledge of IT, ERP, QS systems, and MS Office expertise
- Fluent German and good English skills
- Enjoyment of responsible and meaningful tasks
- Vocational training or Bachelor's degree in relevant fields
- Several years of comparable experience
- First professional experience in QA/QC/production
- Experience in biotech or pharmaceutical industry
- Very good knowledge of GMP/GDP regulatory requirements
- Good knowledge of deviations, CAPAs, and change control
- Good knowledge of IT, ERP, QA systems, and MS Office expertise
- Fluent German and English skills
- Strong self-motivation and team leadership ability
- Enjoyment of responsible and meaningful tasks
Tasks
- Conduct incoming goods inspections
- Perform interim and final inspections of clinical trial samples
- Evaluate and document inspection results
- Prepare GMP-relevant documents like SOPs and specifications
- Ensure adherence to GMP procedures
- Support preparation, review, and approval of qualification and validation documents
- Assess batch-specific quality control activities
- Review batch documentation for completeness and GMP compliance
- Support change control measures and implementation
- Conduct root cause analysis and risk assessment
- Examine and evaluate GxP-relevant deviations
- Develop and implement CAPA measures
- Train quality control staff during induction and ongoing training
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
Tools & Technologies
- MS Office
- IT systems
- ERP systems
- QS data management systems
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PCI GER PCI Pharma Services Germany GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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PCPCI GER PCI Pharma Services Germany GmbH
Quality Control Specialist(m/w/x)
Großbeeren
Full-timeOn-siteExperienced
Nejo AI Summary
Incoming, interim, and final inspections of clinical trial samples, with GMP document preparation. Pharmaceutical quality control experience required. On-site work in a 500+ employee pharmaceutical services provider.
Requirements
- Apprenticeship as PTA, PKA, CTA, or Bachelor's in Pharma
- First professional experience in pharmaceutical quality control
- Very good knowledge of GMP/GDP regulatory requirements
- Good knowledge of deviations, CAPAs, and change control
- Good knowledge of IT, ERP, QS systems, and MS Office expertise
- Fluent German and good English skills
- Enjoyment of responsible and meaningful tasks
- Vocational training or Bachelor's degree in relevant fields
- Several years of comparable experience
- First professional experience in QA/QC/production
- Experience in biotech or pharmaceutical industry
- Very good knowledge of GMP/GDP regulatory requirements
- Good knowledge of deviations, CAPAs, and change control
- Good knowledge of IT, ERP, QA systems, and MS Office expertise
- Fluent German and English skills
- Strong self-motivation and team leadership ability
- Enjoyment of responsible and meaningful tasks
Tasks
- Conduct incoming goods inspections
- Perform interim and final inspections of clinical trial samples
- Evaluate and document inspection results
- Prepare GMP-relevant documents like SOPs and specifications
- Ensure adherence to GMP procedures
- Support preparation, review, and approval of qualification and validation documents
- Assess batch-specific quality control activities
- Review batch documentation for completeness and GMP compliance
- Support change control measures and implementation
- Conduct root cause analysis and risk assessment
- Examine and evaluate GxP-relevant deviations
- Develop and implement CAPA measures
- Train quality control staff during induction and ongoing training
Work Experience
- approx. 1 - 4 years
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
Tools & Technologies
- MS Office
- IT systems
- ERP systems
- QS data management systems
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of PCI GER PCI Pharma Services Germany GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
PCI GER PCI Pharma Services Germany GmbH
Industry
Pharmaceuticals
Description
The company delivers life-changing therapies and is committed to cultivating an inclusive workplace.
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