Novartis Pharmaceutical Manufacturing GmbH
QA Operations Expert(m/w/x)
Full-time/Part-timeWith HomeofficeExperienced
Schaftenau
from 65,605.54 / year
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NONovartis
QA Operations Expert(m/w/x)
Schaftenau
from 65,605.54 / year
Full-time, Part-timeWith Home OfficeExperienced
Nejo AI Summary
Release responsible for regulatory compliance, reviewing PQR/APQR documents, and implementing the Manufacturing Manual. 2+ years QA experience in pharma with cGMP and FDA/EMA track record required. Childcare facilities.
Requirements
- University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
- Professional experience in pharmaceutical industry with direct experience with Pharmaceuticals, Biopharmaceutical or API products and at least 2 years within QA
- Thorough knowledge of cGMP requirements and proven track record with FDA / EMA and other Health Authorities
- Knowledge of GMP and Management of Quality Audits
- Flexibility to work in a fast paced, quickly changing work environment
- Knowledge of Manufacturing Process/ Product Expertise
- Fluent knowledge of English and German (written and spoken)
Tasks
- Oversee GxP functions to ensure product quality
- Implement and govern practices from the Novartis Manufacturing Manual
- Act as the release responsible person for regulatory compliance
- Ensure local HA registration and qualified state of facilities
- Review and approve PQR and APQR documents
- Manage exceptions, deviations, and complaints
- Define and implement CAPAs effectively
- Ensure compliance with cGxP and regulatory requirements
- Adhere to HSE guidelines and requirements
- Collaborate in internal and external audits
- Ensure Quality Assurance Agreements with third parties
- Review and approve MBR, specifications, and test methods
- Participate in the compilation and approval of GxP documents
- Support transfer projects and validation studies
- Author SOPs and other GxP documents as needed
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Attractive incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development opportunities
Career Advancement
- Worldwide career possibilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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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- Novartis Pharmaceutical Manufacturing GmbH
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Full-timeWith HomeofficeExperiencedSchaftenaufrom 64,023.54 / year - Novartis Pharmaceutical Manufacturing GmbH
Senior QA Compliance Specialist(m/w/x)
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NONovartis
QA Operations Expert(m/w/x)
Schaftenau
from 65,605.54 / year
Full-time, Part-timeWith Home OfficeExperienced
Nejo AI Summary
Release responsible for regulatory compliance, reviewing PQR/APQR documents, and implementing the Manufacturing Manual. 2+ years QA experience in pharma with cGMP and FDA/EMA track record required. Childcare facilities.
Requirements
- University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology or equivalent
- Professional experience in pharmaceutical industry with direct experience with Pharmaceuticals, Biopharmaceutical or API products and at least 2 years within QA
- Thorough knowledge of cGMP requirements and proven track record with FDA / EMA and other Health Authorities
- Knowledge of GMP and Management of Quality Audits
- Flexibility to work in a fast paced, quickly changing work environment
- Knowledge of Manufacturing Process/ Product Expertise
- Fluent knowledge of English and German (written and spoken)
Tasks
- Oversee GxP functions to ensure product quality
- Implement and govern practices from the Novartis Manufacturing Manual
- Act as the release responsible person for regulatory compliance
- Ensure local HA registration and qualified state of facilities
- Review and approve PQR and APQR documents
- Manage exceptions, deviations, and complaints
- Define and implement CAPAs effectively
- Ensure compliance with cGxP and regulatory requirements
- Adhere to HSE guidelines and requirements
- Collaborate in internal and external audits
- Ensure Quality Assurance Agreements with third parties
- Review and approve MBR, specifications, and test methods
- Participate in the compilation and approval of GxP documents
- Support transfer projects and validation studies
- Author SOPs and other GxP documents as needed
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Benefits
Competitive Pay
- Market-competitive base salary
Bonuses & Incentives
- Attractive incentive program
Retirement Plans
- Modern company pension scheme
Childcare
- Childcare facilities
Learning & Development
- Learning and development opportunities
Career Advancement
- Worldwide career possibilities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis 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
Novartis
Industry
Pharmaceuticals
Description
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Not a perfect match?
- Novartis Pharmaceutical Manufacturing GmbH
QA Operations Expert(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedSchaftenaufrom 65,605.54 / year - Novartis Pharmaceutical Manufacturing GmbH
QA Specialist Operations(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedKundlfrom 58,199.96 / year - Novartis Pharmaceutical Manufacturing GmbH
QA Specialist Operations(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedKundlfrom 59,781.96 / year - Novartis
QA Compliance Expert(m/w/x)
Full-timeWith HomeofficeExperiencedSchaftenaufrom 64,023.54 / year - Novartis Pharmaceutical Manufacturing GmbH
Senior QA Compliance Specialist(m/w/x)
Full-time/Part-timeWith HomeofficeSeniorSchaftenaufrom 59,781 / year