ProBioGen AG
Quality Assurance (QA) Expert(m/w/x)
Full-timeOn-siteExperienced
Berlin
New Job?Nejo!
The AI Job Search Engine
PCPCI Pharma Services Germany GmbH
Quality Assurance Specialist(m/w/x)
Großbeeren
Full-timeOn-siteExperienced
Nejo AI Summary
Equipment qualification and cleaning process validation for global biopharma therapy production. Expertise in temperature mapping and DQ/IQ/OQ/PQ documentation required. Work in specialized quality department with 2-3 years experience preferred.
Requirements
- 2-3 years quality systems experience
- Expertise in qualification and validation
- Ability to run temperature mappings
- Quality department experience
- Knowledge of QA inspection requirements
- Risk Analysis and associated methodology
- Trained in GMP requirements
- Fluent English and German
- Interpersonal and teamwork skills
- Commitment to Quality Assurance principles
- Analytical approach and detail orientation
- Self-motivation and organization
Tasks
- Qualify and validate equipment, facilities, and utilities
- Validate production and cleaning processes
- Conduct risk analyses for new production processes
- Create comprehensive qualification plans
- Draft and review URS, DQ, IQ, OQ, and PQ documents
- Create process documentation and evaluate results
- Coordinate with departments to drive projects forward
- Support audits regarding qualification and validation
- Manage change controls and deviations
- Execute temperature mappings
- Implement defined quality objectives
- Structure and monitor initiated quality tasks
- Assist with daily Quality Assurance operations
- Develop and review SOPs, instructions, and forms
- Prepare validation documents for cold storage and instruments
- Review and follow the site qualification master plan
- Maintain a register of equipment for qualification
- Discuss validation requirements with customers
- Assign and implement timely corrective actions
- Conduct periodic reviews and re-qualifications
- Perform ongoing process reviews
- Assist with regulatory inspections and customer visits
- Train and support employees on validation topics
Work Experience
- 2 - 3 years
Education
- High school diploma
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- Risk Analysis methodology
- Temperature mappings
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 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.
Not a perfect match?
- PCI Pharma Services Germany GmbH
Qualified Person(m/w/x)
Full-timeOn-siteExperiencedGroßbeeren - Eckert & Ziegler Radiopharma GmbH
IT-Spezialist für Qualifizierung und Validierung in der Pharmaproduktion(m/w/x)
Full-timeOn-siteExperiencedBerlin - Carl Zeiss Meditec AG
Referent Qualitätsmanagement(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Design Assurance Engineer Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin
PCPCI Pharma Services Germany GmbH
Quality Assurance Specialist(m/w/x)
Großbeeren
Full-timeOn-siteExperienced
Nejo AI Summary
Equipment qualification and cleaning process validation for global biopharma therapy production. Expertise in temperature mapping and DQ/IQ/OQ/PQ documentation required. Work in specialized quality department with 2-3 years experience preferred.
Requirements
- 2-3 years quality systems experience
- Expertise in qualification and validation
- Ability to run temperature mappings
- Quality department experience
- Knowledge of QA inspection requirements
- Risk Analysis and associated methodology
- Trained in GMP requirements
- Fluent English and German
- Interpersonal and teamwork skills
- Commitment to Quality Assurance principles
- Analytical approach and detail orientation
- Self-motivation and organization
Tasks
- Qualify and validate equipment, facilities, and utilities
- Validate production and cleaning processes
- Conduct risk analyses for new production processes
- Create comprehensive qualification plans
- Draft and review URS, DQ, IQ, OQ, and PQ documents
- Create process documentation and evaluate results
- Coordinate with departments to drive projects forward
- Support audits regarding qualification and validation
- Manage change controls and deviations
- Execute temperature mappings
- Implement defined quality objectives
- Structure and monitor initiated quality tasks
- Assist with daily Quality Assurance operations
- Develop and review SOPs, instructions, and forms
- Prepare validation documents for cold storage and instruments
- Review and follow the site qualification master plan
- Maintain a register of equipment for qualification
- Discuss validation requirements with customers
- Assign and implement timely corrective actions
- Conduct periodic reviews and re-qualifications
- Perform ongoing process reviews
- Assist with regulatory inspections and customer visits
- Train and support employees on validation topics
Work Experience
- 2 - 3 years
Education
- High school diploma
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- GMP
- Risk Analysis methodology
- Temperature mappings
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 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 Pharma Services Germany GmbH
Industry
Pharmaceuticals
Description
PCI Pharma Services delivers life-changing therapies globally, bridging biopharma companies and patients. They invest in people to drive progress and shape the future.
Not a perfect match?
- ProBioGen AG
Quality Assurance (QA) Expert(m/w/x)
Full-timeOn-siteExperiencedBerlin - PCI Pharma Services Germany GmbH
Qualified Person(m/w/x)
Full-timeOn-siteExperiencedGroßbeeren - Eckert & Ziegler Radiopharma GmbH
IT-Spezialist für Qualifizierung und Validierung in der Pharmaproduktion(m/w/x)
Full-timeOn-siteExperiencedBerlin - Carl Zeiss Meditec AG
Referent Qualitätsmanagement(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Design Assurance Engineer Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin