CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Neuenburg
Neuer Job?Nejo!
Die KI-Suchmaschine für Jobs
BRBristol Myers Squibb
C&Q Engineer(m/w/x)
Boudry
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Equipment validation and qualification for clinical trial operations, applying cGMP and risk-based C&Q strategies. 1+ year pharmaceutical industry experience and cGxP knowledge required. Global clinical trial focus.
Anforderungen
- BS/MS in Engineering/Technical discipline or equivalent experience
- Minimum 1 year of experience in the pharmaceutical industry
- Strong knowledge of international regulatory regulations, cGxP requirements, and best practices
- Proactive and collaborative communication skills
- Problem identification and solution recommendation skills
- Team player with effective interaction skills
- Good level of English
- Ability to communicate in French preferred
Aufgaben
- Perform validation and qualification activities
- Ensure compliance with cGMP and internal policies
- Develop and justify the C&Q approach based on risk and scientific rationale
- Manage continuous improvement topics in equipment risk analysis
- Lead risk assessments and periodic review activities
- Ensure qualification and validation of equipment and systems
- Author and review qualification documents as needed
- Execute re-qualification and periodic review activities
- Contribute to the development of local site procedures
- Review change controls and maintenance interventions
- Coordinate qualification and validation execution activities
- Participate in internal and external audits as a subject matter expert
- Establish effective relationships with internal teams, customers, and suppliers
- Proactively identify problems and propose solutions
- Complete work independently while seeking guidance on complex tasks
- Participate in projects and initiatives as directed
Berufserfahrung
- 1 Jahr
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Bristol Myers Squibb 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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- Bristol Myers Squibb
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VollzeitPraktikumnur vor OrtBoudry - Takeda
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Vollzeitnur vor OrtBerufserfahrenNeuenburg - Takeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
Vollzeitnur vor OrtManagementZürich, Neuenburg, Oranienburg
BRBristol Myers Squibb
C&Q Engineer(m/w/x)
Boudry
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Equipment validation and qualification for clinical trial operations, applying cGMP and risk-based C&Q strategies. 1+ year pharmaceutical industry experience and cGxP knowledge required. Global clinical trial focus.
Anforderungen
- BS/MS in Engineering/Technical discipline or equivalent experience
- Minimum 1 year of experience in the pharmaceutical industry
- Strong knowledge of international regulatory regulations, cGxP requirements, and best practices
- Proactive and collaborative communication skills
- Problem identification and solution recommendation skills
- Team player with effective interaction skills
- Good level of English
- Ability to communicate in French preferred
Aufgaben
- Perform validation and qualification activities
- Ensure compliance with cGMP and internal policies
- Develop and justify the C&Q approach based on risk and scientific rationale
- Manage continuous improvement topics in equipment risk analysis
- Lead risk assessments and periodic review activities
- Ensure qualification and validation of equipment and systems
- Author and review qualification documents as needed
- Execute re-qualification and periodic review activities
- Contribute to the development of local site procedures
- Review change controls and maintenance interventions
- Coordinate qualification and validation execution activities
- Participate in internal and external audits as a subject matter expert
- Establish effective relationships with internal teams, customers, and suppliers
- Proactively identify problems and propose solutions
- Complete work independently while seeking guidance on complex tasks
- Participate in projects and initiatives as directed
Berufserfahrung
- 1 Jahr
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Französisch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Bristol Myers Squibb 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
Bristol Myers Squibb
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to transforming patients’ lives through science and promotes global participation in clinical trials.
Noch nicht perfekt?
- CHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - Bristol Myers Squibb
QC Apprentice(m/w/x)
VollzeitLehrenur vor OrtBoudry - Bristol Myers Squibb
Metrology Intern – Specialist Documentation & Data Management(m/w/x)
VollzeitPraktikumnur vor OrtBoudry - Takeda
Product Quality Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenNeuenburg - Takeda Manufacturing Austria AG
Associate Director, API Process Engineering(m/w/x)
Vollzeitnur vor OrtManagementZürich, Neuenburg, Oranienburg