Lonza
(Senior) QA Qualification Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Visp
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Daily qualification of cGMP drug product facilities, equipment, and systems. Subject matter expertise in cGMP compliant qualification required. Compensation programs for high performance, lifestyle, family, and leisure benefits.
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Anforderungen
- Academic degree in Engineering, Chemistry, or Biotechnology
- Significant pharmaceutical Drug Product industry experience, ideally QA role
- Good understanding of applicable cGMP regulations
- General knowledge of engineering and manufacturing processes
- Subject matter expertise in cGMP compliant qualification
- Ability to work autonomously with established procedures
- Excellent verbal, written, and interpersonal communication skills in German and English
- Attention to accuracy and detail
- Ability to work in partnership as active team member
- Strong individual contributor and decision maker
Aufgaben
- Own quality responsibilities for daily qualification activities of facilities, equipment, and systems for cGMP manufacture of drug products
- Compile, review, and release qualification documents, including URS, Qualification Plan & Report, and DQ/IQ/OQ/PQ Reports
- Perform assessments and approvals of technical change requests and their relevance to the qualified state of equipment, utilities, and systems
- Support and approve quality risk analyses, such as FMEA
- Ensure relevant deviations are appropriately investigated and recorded in Deviation Reports
- Drive CAPA and Effectiveness Checks items to completion and timely closing
- Confirm the qualified state of facilities, equipment, and systems throughout their life cycles via periodic reviews or re-qualifications
- Ensure documents are correct and adhere to SOPs and customer requirements
- Represent specific areas as a Subject Matter Expert (SME), providing guidance and recommendations to internal customers
- Lead or support specific projects in your SME area to develop quality standards
- Write or revise SOPs in your SME area and act as owner of these documents
- Enhance quality knowledge by following quality standards and attending training courses/congresses
- Identify areas of non-compliance through internal audits or other observations
- Represent qualification topics during customer audits and regulatory inspections
- Support cGMP training programs to ensure staff is trained
- Train and mentor junior employees to perform duties as quality professionals
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Compensation programs for high performance
Mitarbeiterrabatte
- Lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic work culture
- Inclusive workplace
Sinnstiftende Arbeit
- Ethical workplace
Sonstige Vorteile
- Tailored local benefits
- Relocation assistance
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza 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.
Zur Originalanzeige bei LonzaÜber das Unternehmen
LO
PharmaceuticalsVisp
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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