Novartis
QA Operations Expert(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahren
Schaftenau
ab 65.605,54 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
NONovartis Pharmaceutical Manufacturing GmbH
Senior QA Operations Expert; Qualified Person(m/w/x)
Schaftenau
ab 73.122,9 / Jahr
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Certifying and releasing secondary packed drug product batches for commercial purposes at a pharmaceutical manufacturing site. Proven experience in Audit and Inspection Management required. 4-day work week, company car for private use.
Anforderungen
- Proven experience in Audit and Inspection Management
- Strong working knowledge of cGMP and GxP requirements
- Hands-on experience with Release Management and batch disposition
- Solid expertise in Quality Management Systems (QMS), Quality Assurance, and Quality Compliance
- Background in Technical Operations with technological aptitude
- Demonstrated people leadership capability
- Sound decision-making in patient-focused environment
- Strong collaboration skills
- Strong communication skills
- Strong problem-solving skills
- Ability to navigate ambiguity effectively
- High commitment to data integrity
- Digital proficiency
- Audit & Inspection Management experience
- Good Manufacturing Practices (cGMP) knowledge
- Release Management experience
- Quality Management Systems knowledge
- Technical Operations experience
- GxP Experience
- People Management experience
- Quality Assurance knowledge
- Quality Compliance knowledge
- Technological Expertise
- Patient Safety focus
- Collaboration skills
- Regulatory requirements knowledge
- Dealing with ambiguity
- Problem Solving Skills
- Communication skills
- Data Integrity commitment
- Digital saviness
- Leadership skills
- Decision Making skills
Aufgaben
- Certify and release secondary packed drug product batches for commercial purposes
- Ensure compliance with AMG, Marketing Authorization, and GMP requirements
- Verify product quality and documentation for batch release
- Lead critical negotiations with internal and external stakeholders
- Provide coaching, performance management, and capability building
- Manage technical operations and provide day-to-day quality support
- Collaborate across functions to align on priorities, risks, and delivery commitments
- Participate in escalations, recalls, and critical complaint investigations
- Evaluate process changes and deviations
- Plan and deliver projects to agreed quality, scope, and timelines
- Ensure inspection and audit readiness
- Coordinate responses and drive timely, sustainable CAPAs
- Support preparation for and participation in audits and inspections
- Maintain and improve Quality Management System processes
- Oversee release management activities
- Report technical complaints, adverse events, and special case scenarios within 24 hours
- Coordinate distribution of marketing samples as needed
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- cGMP
- GxP
- QMS
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.
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NONovartis Pharmaceutical Manufacturing GmbH
Senior QA Operations Expert; Qualified Person(m/w/x)
Schaftenau
ab 73.122,9 / Jahr
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
Certifying and releasing secondary packed drug product batches for commercial purposes at a pharmaceutical manufacturing site. Proven experience in Audit and Inspection Management required. 4-day work week, company car for private use.
Anforderungen
- Proven experience in Audit and Inspection Management
- Strong working knowledge of cGMP and GxP requirements
- Hands-on experience with Release Management and batch disposition
- Solid expertise in Quality Management Systems (QMS), Quality Assurance, and Quality Compliance
- Background in Technical Operations with technological aptitude
- Demonstrated people leadership capability
- Sound decision-making in patient-focused environment
- Strong collaboration skills
- Strong communication skills
- Strong problem-solving skills
- Ability to navigate ambiguity effectively
- High commitment to data integrity
- Digital proficiency
- Audit & Inspection Management experience
- Good Manufacturing Practices (cGMP) knowledge
- Release Management experience
- Quality Management Systems knowledge
- Technical Operations experience
- GxP Experience
- People Management experience
- Quality Assurance knowledge
- Quality Compliance knowledge
- Technological Expertise
- Patient Safety focus
- Collaboration skills
- Regulatory requirements knowledge
- Dealing with ambiguity
- Problem Solving Skills
- Communication skills
- Data Integrity commitment
- Digital saviness
- Leadership skills
- Decision Making skills
Aufgaben
- Certify and release secondary packed drug product batches for commercial purposes
- Ensure compliance with AMG, Marketing Authorization, and GMP requirements
- Verify product quality and documentation for batch release
- Lead critical negotiations with internal and external stakeholders
- Provide coaching, performance management, and capability building
- Manage technical operations and provide day-to-day quality support
- Collaborate across functions to align on priorities, risks, and delivery commitments
- Participate in escalations, recalls, and critical complaint investigations
- Evaluate process changes and deviations
- Plan and deliver projects to agreed quality, scope, and timelines
- Ensure inspection and audit readiness
- Coordinate responses and drive timely, sustainable CAPAs
- Support preparation for and participation in audits and inspections
- Maintain and improve Quality Management System processes
- Oversee release management activities
- Report technical complaints, adverse events, and special case scenarios within 24 hours
- Coordinate distribution of marketing samples as needed
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- cGMP
- GxP
- QMS
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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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 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
QA Compliance Expert(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenSchaftenauab 64.023,54 / Jahr - Novartis Pharmaceutical Manufacturing GmbH
QA Specialist Operations(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenKundlab 59.781,96 / Jahr