Novartis
QA Operations Expert(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahren
Schaftenau
ab 65.605,54 / Jahr
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NONovartis Pharmaceutical Manufacturing GmbH
QA Operations Expert(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeit, Teilzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Acting as release responsible for regulatory compliance of pharmaceutical products at a global medicine company, reviewing PQR/APQR documents. University degree in life sciences and 2+ years direct QA experience in pharma required. On-site childcare facilities.
Anforderungen
- 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)
- Continued Learning, Employee Performance Evaluations, Gmp Procedures, Managing Ambiguity, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Attraktive Vergütung
- Market-competitive base salary
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development opportunities
Karriere- und Weiterentwicklung
- Worldwide career possibilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Novartis Pharmaceutical Manufacturing GmbH
QA Specialist Operations(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenKundlab 58.199,96 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
QA Specialist Operations(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenKundlab 59.781,96 / Jahr - Novartis
QA Compliance Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenSchaftenauab 64.023,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior QA Compliance Specialist(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorSchaftenauab 59.781 / Jahr
NONovartis Pharmaceutical Manufacturing GmbH
QA Operations Expert(m/w/x)
Schaftenau
ab 65.605,54 / Jahr
Vollzeit, Teilzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Acting as release responsible for regulatory compliance of pharmaceutical products at a global medicine company, reviewing PQR/APQR documents. University degree in life sciences and 2+ years direct QA experience in pharma required. On-site childcare facilities.
Anforderungen
- 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)
- Continued Learning, Employee Performance Evaluations, Gmp Procedures, Managing Ambiguity, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence
Aufgaben
- 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
Berufserfahrung
- 2 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Benefits
Attraktive Vergütung
- Market-competitive base salary
Boni & Prämien
- Attractive incentive program
Betriebliche Altersvorsorge
- Modern company pension scheme
Kinderbetreuung
- Childcare facilities
Weiterbildungsangebote
- Learning and development opportunities
Karriere- und Weiterentwicklung
- Worldwide career possibilities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Pharmaceutical Manufacturing GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Novartis Pharmaceutical Manufacturing GmbH
Branche
Pharmaceuticals
Beschreibung
The company aims to reimagine medicine to improve and extend people’s lives.
Noch nicht perfekt?
- Novartis
QA Operations Expert(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenSchaftenauab 65.605,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
QA Specialist Operations(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenKundlab 58.199,96 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
QA Specialist Operations(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenKundlab 59.781,96 / Jahr - Novartis
QA Compliance Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenSchaftenauab 64.023,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
Senior QA Compliance Specialist(m/w/x)
Vollzeit/Teilzeitmit HomeofficeSeniorSchaftenauab 59.781 / Jahr