Overview
Senior Quality Systems Manager Jobs in Visp, Valais, Switzerland at Actalent
Title: Senior Quality Systems Manager
Company: Actalent
Location: Visp, Valais, Switzerland
We are seeking a Senior Quality Systems Manager to ensure compliance with ISO/cGMP quality system requirements. The ideal candidate has in-depth knowledge of PICS Guide to Good Manufacturing Practices (Parts 1 and 2) or the EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, including Annex 1.
Responsibilities:
Verify compliance with ISO/cGMP quality system requirements.
Provide immediate support to operations and quality control staff for compliance-related concerns (QA “on-the-floor” support).
Make independent quality-related decisions based on regulatory and compliance knowledge.
Provide independent quality support to project teams.
Audit internal quality system elements in manufacturing and operational support areas.
Oversee compliance of Change Controls, CA/PA, investigations, OOS, and deviations.
Perform external audits of suppliers/vendors/off-site facilities.
Lead and direct the work of others as needed.
Review and approve validation documents.
Review and Master Batch Records (MBR) and supporting documents.
Must-Haves:
Direct QA commercial drug substance/drug product experience or equivalent aseptic processing and cell therapy manufacturing experience.
GMP compliance and Part 11 compliance knowledge preferred.
Experience with oversight of aseptic processing and associated international regulations.
Proficiency in Microsoft Office and database management.
5-10 years of relevant experience.
Location: Visp
Duration: 6 months
Start date: ASAP
If you feel confident about this opportunity, we encourage you to apply, or to reach out to me via email at [email protected]
*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.
