Dr. Franz Köhler Chemie GmbH
Mitarbeiter Qualitätssicherung / CAPA-Management und Non-Konformitäten(m/w/x)
Full-timeWith HomeofficeSenior
Alsbach-Hähnlein
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EVEvonik Operations GmbH
Senior Quality Manager for Product Lifecycle Projects(m/w/x)
Darmstadt
Full-timeWith Home OfficeSenior
Green Job
Nejo AI Summary
Quality assurance for medical/pharma products, including GMP specs, supplier qualification, and change control. Solid ISO 13485 knowledge and leadership experience required. Hybrid and flexible working environment.
Requirements
- Completed scientific degree in chemistry, pharmacy, or biology, preferably with a doctorate
- Solid knowledge of ISO 13485 and additional regulations in quality and risk management and pharmacy
- Leadership experience
- Experience in project management and knowledge of Lean Quality and quality tools
- Knowledge of production processes and facilities for medical technology or pharmaceutical products under GMP conditions, preferably in the polymer field
- Knowledge of supplier management and auditing experience
- Excellent verbal and written communication skills in German and English
- Strong analytical skills, high problem-solving competence, and strong team orientation
Tasks
- Create GMP specifications for raw materials and finished products
- Support the preparation of technical finished product specifications
- Conduct supplier qualifications and qualify external service providers as needed
- Create and track quality assurance agreements with contract manufacturers
- Create and track change control requests
- Support process validation activities
- Review manufacturing instructions and validation documents during method validation
- Prepare quality reviews for products, raw materials, media, and equipment
- Handle deviations, complaints, and CAPA during product introduction
- Provide audit support and manage audits when necessary
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Bonuses & Incentives
- Performance-based remuneration
Other Benefits
- Occupational health benefits
Flexible Working
- Hybrid working environment
- Flexible working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Evonik Operations 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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EVEvonik Operations GmbH
Senior Quality Manager for Product Lifecycle Projects(m/w/x)
Darmstadt
Full-timeWith Home OfficeSenior
Green Job
Nejo AI Summary
Quality assurance for medical/pharma products, including GMP specs, supplier qualification, and change control. Solid ISO 13485 knowledge and leadership experience required. Hybrid and flexible working environment.
Requirements
- Completed scientific degree in chemistry, pharmacy, or biology, preferably with a doctorate
- Solid knowledge of ISO 13485 and additional regulations in quality and risk management and pharmacy
- Leadership experience
- Experience in project management and knowledge of Lean Quality and quality tools
- Knowledge of production processes and facilities for medical technology or pharmaceutical products under GMP conditions, preferably in the polymer field
- Knowledge of supplier management and auditing experience
- Excellent verbal and written communication skills in German and English
- Strong analytical skills, high problem-solving competence, and strong team orientation
Tasks
- Create GMP specifications for raw materials and finished products
- Support the preparation of technical finished product specifications
- Conduct supplier qualifications and qualify external service providers as needed
- Create and track quality assurance agreements with contract manufacturers
- Create and track change control requests
- Support process validation activities
- Review manufacturing instructions and validation documents during method validation
- Prepare quality reviews for products, raw materials, media, and equipment
- Handle deviations, complaints, and CAPA during product introduction
- Provide audit support and manage audits when necessary
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Bonuses & Incentives
- Performance-based remuneration
Other Benefits
- Occupational health benefits
Flexible Working
- Hybrid working environment
- Flexible working environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Evonik Operations 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
Evonik Operations GmbH
Industry
Other
Description
Das Unternehmen entwickelt innovative Lösungen für eine nachhaltigere und gesündere Welt.
Not a perfect match?
- Dr. Franz Köhler Chemie GmbH
Mitarbeiter Qualitätssicherung / CAPA-Management und Non-Konformitäten(m/w/x)
Full-timeWith HomeofficeSeniorAlsbach-Hähnlein - Thermo Fisher Scientific
Senior Account Manager - Bioproduction(m/w/x)
Full-timeRemoteSeniorDarmstadt - Dr. Franz Köhler Chemie GmbH
Pharmaziepraktikant:in - Qualitätskontrolle(m/w/x)
Full-timeInternshipWith HomeofficeAlsbach-Hähnlein - Evonik Operations GmbH
Prozessingenieur(m/w/x)
Full-timeWith HomeofficeExperiencedDarmstadt - CWS Hygiene International GmbH
Senior ERP Functional Consultant(m/w/x)
Full-timeWith HomeofficeSeniorDreieich