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QA Specialist m/w/d (DE)
[16509]
Batch record review, GMP
Zu besetzendes Projekt: QA Specialist m/w/d Art der Beschäftigung: Payroll Branche: Biotech Fähigkeiten: Quality Control,Batch Record Projektstart: 01.09.2025 Projektdauer: 12 Monate Einsatzort: Luzern, Schweiz Responsibilities: ·Review and approve Master batch records and ensure conformance to all applicable policies/procedure and compliance with all governing regulations. ·Manage routine and complex deviations ·Support process and analytical change requests. ·Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine. ·Support routine process validation; review and approve validation reports/tech transfer ·Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes. ·Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums. ·Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred. Required Skills: ·Solves complex problems; takes a new perspective using existing solutions. ·Works independently, receives minimal guidance. ·Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME. ·May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others. ·Explains difficult issues and works to build alignment around a complex situation. ·Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills. ·Strong knowledge of External Manufacturing management, supply chain, and operations. ·Fluent in English, German language skills are of advantage. (Initial Master Batch Record Reviews will be in German, it would be great for them to speak German)
- Review and approve Master batch records and ensure conformance to all applicable policies/procedure and compliance with all governing regulations.
- Manage routine and complex deviations
- Support process and analytical change requests.
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine.
- Support routine process validation; review and approve validation reports/tech transfer
- Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes.
- Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.
- Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred.
- Solves complex problems; takes a new perspective using existing solutions.
- Works independently, receives minimal guidance.
- Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME.
- May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.
- Explains difficult issues and works to build alignment around a complex situation.
- Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.
- Strong knowledge of External Manufacturing management, supply chain, and operations.
- Fluent in English, German language skills are of advantage. (Initial Master Batch Record Reviews will be in German, it would be great for them to speak German)
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