Novartis Radiopharmaceuticals GmbH
Production Technician / Produktionmitarbeiter(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Halle (Saale)
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NONovartis Radiopharmaceuticals GmbH
Process Expert(m/w/x)
Halle (Saale)
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Driving root cause investigations for product and process issues, ensuring compliant batch manufacturing at a large pharmaceutical manufacturer. 3 years' shop floor process support experience in GMP manufacturing, with compliance investigations, required. On-site manufacturing environment.
Anforderungen
- Bachelor’s degree in engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience
- 3 years’ experience in process support shop floor role in GMP manufacturing and/or QA/QC
- Proven process understanding (Pharma, GMP, Regulatory aspects)
- Strong awareness of quality issues
- Compliance investigations experience
- Excellent technical writing skills
- Fluent German and English skills
- Previous Radiopharma experience (advantageous)
- Prior leadership and/or high cross-functional experience (preferred)
Aufgaben
- Provide front-line manufacturing support.
- Ensure safe and compliant batch manufacturing.
- Act as Subject Matter Expert (SME).
- Serve as first point of contact for product and process issues.
- Drive investigations to root cause.
- Implement corrective and preventive actions (CAPAs).
- Manage and maintain Master Batch Records.
- Manage and maintain Standard Operating Procedures (SOPs).
- Manage and maintain risk assessments and protocols.
- Write and review SOPs, batch records, and white papers.
- Collect data for ongoing process verification (OPV).
- Track and evaluate product performance.
- Support CAPA implementation.
- Author and own material transfer investigations.
- Author and own API synthesis investigations.
- Author and own Drug Substance formulation investigations.
- Author and own Drug product filling investigations.
- Author and own inspection and packaging investigations.
- Ensure processes are inspection-ready.
- Support process optimization and new technology introduction.
- Review validation protocols and reports.
- Support execution of process validations.
- Support short-term improvement projects.
- Guide and support production teams.
- Train and share knowledge with production teams.
- Guide processes to closure and completion.
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Radiopharmaceuticals 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?
- Simtra BioPharma Solutions
Spezialist Qualitätssicherung in der Produktion(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale) - Novartis Radiopharmaceuticals GmbH
Production Technician / Produktionmitarbeiter(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale) - Simtra BioPharma Solutions
Specialist QA CAPA Management(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale) - Simtra BioPharma Solutions
Spezialist Inprozesskontrolle(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale)
NONovartis Radiopharmaceuticals GmbH
Process Expert(m/w/x)
Halle (Saale)
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Driving root cause investigations for product and process issues, ensuring compliant batch manufacturing at a large pharmaceutical manufacturer. 3 years' shop floor process support experience in GMP manufacturing, with compliance investigations, required. On-site manufacturing environment.
Anforderungen
- Bachelor’s degree in engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience
- 3 years’ experience in process support shop floor role in GMP manufacturing and/or QA/QC
- Proven process understanding (Pharma, GMP, Regulatory aspects)
- Strong awareness of quality issues
- Compliance investigations experience
- Excellent technical writing skills
- Fluent German and English skills
- Previous Radiopharma experience (advantageous)
- Prior leadership and/or high cross-functional experience (preferred)
Aufgaben
- Provide front-line manufacturing support.
- Ensure safe and compliant batch manufacturing.
- Act as Subject Matter Expert (SME).
- Serve as first point of contact for product and process issues.
- Drive investigations to root cause.
- Implement corrective and preventive actions (CAPAs).
- Manage and maintain Master Batch Records.
- Manage and maintain Standard Operating Procedures (SOPs).
- Manage and maintain risk assessments and protocols.
- Write and review SOPs, batch records, and white papers.
- Collect data for ongoing process verification (OPV).
- Track and evaluate product performance.
- Support CAPA implementation.
- Author and own material transfer investigations.
- Author and own API synthesis investigations.
- Author and own Drug Substance formulation investigations.
- Author and own Drug product filling investigations.
- Author and own inspection and packaging investigations.
- Ensure processes are inspection-ready.
- Support process optimization and new technology introduction.
- Review validation protocols and reports.
- Support execution of process validations.
- Support short-term improvement projects.
- Guide and support production teams.
- Train and share knowledge with production teams.
- Guide processes to closure and completion.
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis Radiopharmaceuticals 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 Radiopharmaceuticals GmbH
Branche
Pharmaceuticals
Beschreibung
Novartis Radiopharmaceuticals GmbH is a manufacturing plant for Radioligand Therapy (RLT) drug products.
Noch nicht perfekt?
- Novartis Radiopharmaceuticals GmbH
Production Technician / Produktionmitarbeiter(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale) - Simtra BioPharma Solutions
Spezialist Qualitätssicherung in der Produktion(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale) - Novartis Radiopharmaceuticals GmbH
Production Technician / Produktionmitarbeiter(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale) - Simtra BioPharma Solutions
Specialist QA CAPA Management(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale) - Simtra BioPharma Solutions
Spezialist Inprozesskontrolle(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHalle (Saale)