Debiopharm
Pharmaceutical Quality (pQM) Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Lausanne
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
FEFerring Pharmaceuticals
QA QMS Senior Specialist(m/w/x)
Saint-Prex
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading deviation management and self-inspection programs for GMP-regulated pharmaceuticals. Bachelor's or Master's degree in a scientific discipline required. Inclusive support package, parental leave for all parents.
Anforderungen
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related scientific discipline
- Proven experience in Quality Assurance and Quality Management Systems within a GMP-regulated pharmaceutical or biotechnology environment
- Strong knowledge of deviation management, self-inspections, CAPA, and inspection readiness activities
- Experience in drafting, reviewing, and approving GMP documentation, procedures, protocols, and quality records
- Ability to train and support cross-functional stakeholders on quality systems and compliance expectations
- Experience participating in Health Authority inspections and/or supplier audits
- Strong analytical skills with ability to trend data, identify compliance risks, and support continuous improvement
- Excellent written and spoken English skills, with ability to draft clear GMP documentation and communicate effectively with cross-functional and international stakeholders
- Experience with Electronic Quality Systems such as TrackWise and Veeva
- Knowledge of Pharmacopoeia regulatory surveillance processes
- Good knowledge of GMP/GxP requirements, quality systems governance, inspection management, root cause analysis, CAPA processes, and quality reporting tools
Aufgaben
- Ensure effective implementation of QMS processes
- Maintain GMP compliance and operational excellence
- Lead Deviation Management System
- Coordinate self-inspection program
- Plan and analyze self-inspection data
- Report self-inspection findings
- Support self-inspection contributors
- Prepare for Health Authority inspections
- Represent QMS during inspections
- Review and approve quality records
- Review and approve procedures
- Review and approve protocols
- Review and approve reports
- Provide QA oversight for training
- Train new employees on GMP systems
- Train new employees on quality processes
- Support regulatory surveillance
- Review Pharmacopoeias reports
- Improve Pharmacopoeias processes
- Drive continuous improvement initiatives
- Support site GxP compliance
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- TrackWise
- Veeva
Benefits
Sonstige Vorteile
- Inclusive support package
Familienfreundlichkeit
- Equal and accessible policies for family building
- Extended support on family building journey
Großzügige Elternzeit
- Parental leave for birthing parents
- Parental leave for non-birthing parents
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Ferring Pharmaceuticals 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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Leading deviation management and self-inspection programs for GMP-regulated pharmaceuticals. Bachelor's or Master's degree in a scientific discipline required. Inclusive support package, parental leave for all parents.
Anforderungen
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related scientific discipline
- Proven experience in Quality Assurance and Quality Management Systems within a GMP-regulated pharmaceutical or biotechnology environment
- Strong knowledge of deviation management, self-inspections, CAPA, and inspection readiness activities
- Experience in drafting, reviewing, and approving GMP documentation, procedures, protocols, and quality records
- Ability to train and support cross-functional stakeholders on quality systems and compliance expectations
- Experience participating in Health Authority inspections and/or supplier audits
- Strong analytical skills with ability to trend data, identify compliance risks, and support continuous improvement
- Excellent written and spoken English skills, with ability to draft clear GMP documentation and communicate effectively with cross-functional and international stakeholders
- Experience with Electronic Quality Systems such as TrackWise and Veeva
- Knowledge of Pharmacopoeia regulatory surveillance processes
- Good knowledge of GMP/GxP requirements, quality systems governance, inspection management, root cause analysis, CAPA processes, and quality reporting tools
Aufgaben
- Ensure effective implementation of QMS processes
- Maintain GMP compliance and operational excellence
- Lead Deviation Management System
- Coordinate self-inspection program
- Plan and analyze self-inspection data
- Report self-inspection findings
- Support self-inspection contributors
- Prepare for Health Authority inspections
- Represent QMS during inspections
- Review and approve quality records
- Review and approve procedures
- Review and approve protocols
- Review and approve reports
- Provide QA oversight for training
- Train new employees on GMP systems
- Train new employees on quality processes
- Support regulatory surveillance
- Review Pharmacopoeias reports
- Improve Pharmacopoeias processes
- Drive continuous improvement initiatives
- Support site GxP compliance
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- TrackWise
- Veeva
Benefits
Sonstige Vorteile
- Inclusive support package
Familienfreundlichkeit
- Equal and accessible policies for family building
- Extended support on family building journey
Großzügige Elternzeit
- Parental leave for birthing parents
- Parental leave for non-birthing parents
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Ferring Pharmaceuticals 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
Ferring Pharmaceuticals
Branche
Pharmaceuticals
Beschreibung
The company helps people build families and live better lives through scientific advances in reproductive and women's health, gastroenterology, and urology.
Noch nicht perfekt?
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