PCI Pharma Services Germany GmbH
Quality Assurance Specialist(m/w/x)
Full-timeOn-siteExperienced
Großbeeren
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PCPCI Pharma Services Germany GmbH
Qualified Person(m/w/x)
Großbeeren
Full-timeOn-siteExperienced
Nejo AI Summary
Batch certification and GMP auditing for sterile and large molecule biopharmaceuticals at global CDMO. Extensive experience in QP certification and EU GMP audits required. International travel for third-country site inspections.
Requirements
- Experience in QP certification activities
- Experience in sterile dosage forms
- Experience in non-sterile dosage forms
- Experience in large molecule biopharmaceuticals
- Experience in EU GMP audits
- Experience in pharmaceutical packaging and processing
- Experience working in global organisations
- High level knowledge of GxPs
- Knowledge of Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis principles and methodology
- Eligibility to act as Qualified Person
- Pharmacist degree level education
- Business fluent German and English
- Good interpersonal and interaction skills
- Ability to prioritise competing needs
- Good written communication skills
- Good teamworking and leadership skills
- Ability to coach and mentor staff
Tasks
- Maintain compliance with GMP, customer Quality Agreements, and German legal frameworks
- Adhere to LAVG licenses and EU GMP Directives and Guidelines
- Review Batch Manufacturing Documents for EU GMP and marketing authorization compliance
- Certify medicinal products for use inside and outside the EU
- Audit manufacturing sites in EU and third countries for GMP compliance
- Review PCI Project Files to ensure regulatory and procedural compliance
- Contribute to the PCI Quality Management System
- Assist with regulatory inspections and client audits
- Identify and support internal process and procedure improvements
- Support site-wide training for commercial and clinical activities
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GxPs
- Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis methodology
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.
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PCPCI Pharma Services Germany GmbH
Qualified Person(m/w/x)
Großbeeren
Full-timeOn-siteExperienced
Nejo AI Summary
Batch certification and GMP auditing for sterile and large molecule biopharmaceuticals at global CDMO. Extensive experience in QP certification and EU GMP audits required. International travel for third-country site inspections.
Requirements
- Experience in QP certification activities
- Experience in sterile dosage forms
- Experience in non-sterile dosage forms
- Experience in large molecule biopharmaceuticals
- Experience in EU GMP audits
- Experience in pharmaceutical packaging and processing
- Experience working in global organisations
- High level knowledge of GxPs
- Knowledge of Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis principles and methodology
- Eligibility to act as Qualified Person
- Pharmacist degree level education
- Business fluent German and English
- Good interpersonal and interaction skills
- Ability to prioritise competing needs
- Good written communication skills
- Good teamworking and leadership skills
- Ability to coach and mentor staff
Tasks
- Maintain compliance with GMP, customer Quality Agreements, and German legal frameworks
- Adhere to LAVG licenses and EU GMP Directives and Guidelines
- Review Batch Manufacturing Documents for EU GMP and marketing authorization compliance
- Certify medicinal products for use inside and outside the EU
- Audit manufacturing sites in EU and third countries for GMP compliance
- Review PCI Project Files to ensure regulatory and procedural compliance
- Contribute to the PCI Quality Management System
- Assist with regulatory inspections and client audits
- Identify and support internal process and procedure improvements
- Support site-wide training for commercial and clinical activities
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- GxPs
- Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis methodology
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?
- PCI Pharma Services Germany GmbH
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