3626 BURGWEDEL BIOTECH GMBH
Computer System Validation Specialist - Engineering Human Health (m/w/x)
Vollzeitmit HomeofficeBerufserfahren
Burgwedel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
MEMerck & Co., Inc., Rahway, NJ, USA
Senior CSV Quality Assurance Specialist (m/w/x)
Vollzeitmit HomeofficeManagement
Nejo KI-Zusammenfassung
Leading risk-based CSV validation for biopharmaceutical systems. Bachelor's degree in Science, IT, or Engineering required. 13 monthly salaries, attractive pension scheme.
Deine Match-Analyse
von deinem Karriere-Agenten
Warum dieser Job zu dir passt
Mögliche Lücken
Tipps für deine Bewerbung
Anforderungen
- Bachelor's degree in Science, IT, Engineering or equivalent
- At least five years of demonstrable experience delivering IT solutions or application support
- Lab experience is a plus
- Knowledge of CSA, Annex 11, Annex 22, GAMP5 concepts and regulations
- Strong understanding of pharmaceutical industry and regulations (FDA/EU/ICH)
- Emphasis in 21 CFR Part 11, 210, 211, 820, CSA, Annex 11, Annex 22, GAMP5 concepts and regulations
- Familiarity or practical experience implementing quality systems in pharma/lab/biotech manufacturing
- Strong analytical and problem-solving skills
- Strong communication and teamwork skills
- Timely decision-making and ability to handle changing priorities
- Project management skills, sense of urgency, track record of quality deliverables
- Extended experience with deviations, CAPA, change control, master data, qualification/validation, inspection readiness in GxP environment
- Excellent written and spoken German skills
- Excellent written and spoken English skills
- Adaptability
- Biopharmaceutical Industry knowledge
- cGMP Regulations knowledge
- Change Management knowledge
- Data Integrity knowledge
- Data Quality knowledge
- Deviation Management knowledge
- Driving Continuous Improvement
- Emerging Trends awareness
- GMP Compliance knowledge
- Good Automated Manufacturing Practice (GAMP) knowledge
- Inspection Readiness knowledge
- Manufacturing Quality Control knowledge
- Master Data Management (MDM) knowledge
- Pharmaceutical Quality Assurance knowledge
- Pharmacy Regulation knowledge
- Product Disposition knowledge
- Project Management knowledge
- Quality Auditing knowledge
- Quality Management Standards knowledge
- Quality Standards knowledge
- Regulatory Compliance knowledge
- Risk Management knowledge
- Self Motivation
Aufgaben
- Lead risk-based CSV and validate systems
- Ensure inspection readiness
- Act as a change driver for site processes
- Review and approve quality-related activities
- Contribute to site inspection readiness
- Introduce strategic initiatives for standardization
- Represent DDQ in global governance meetings
- Promote cGMP and Data Integrity awareness
- Support a culture of continuous improvement
- Develop and maintain training on CSV and data integrity
- Resolve regulatory non-conformances for cGMP computerized systems
- Drive improvements based on emerging trends and compliance gaps
- Act as a representative for DDQ management in meetings
Berufserfahrung
5 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Tools & Technologien
CSAAnnex 11Annex 22GAMP5FDAEUICH21 CFR Part 11210211820GxP
Benefits
Flexibles Arbeiten
- Flexible working hours
- Hybrid working model
Betriebliche Altersvorsorge
- Attractive company pension scheme
Sonstige Zulagen
- 13 monthly salaries
Boni & Prämien
- Target bonus
Mehr Urlaubstage
- 30 days holiday entitlement
Weiterbildungsangebote
- Internal training
- Training on the job
- Insights into medicinal product development
Karriere- und Weiterentwicklung
- Promotion opportunities
Sonstige Vorteile
- International co-operations
- Working across borders
Abwechslungsreiche Aufgaben
- Contributing own ideas to process design
Mitarbeiterrabatte
- Corporate benefits
Parkplatz & Pendelvorteile
- Free car parking
Großzügige Elternzeit
- Paid Parental Time Off
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Merck & Co., Inc., Rahway, NJ, USA 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 Merck & Co., Inc., Rahway, NJ, USAÜber das Unternehmen
ME
PharmaceuticalsBurgwedel
Merck & Co., Inc. is a global biopharmaceutical company committed to discovering, developing, manufacturing, and marketing a broad range of innovative health care products.
Wie gut ist dein Lebenslauf?
Nejo bewertet ihn, und bringt ihn danach gemeinsam mit dir in Bestform.
Du hast noch keinen Lebenslauf?