Senior Quality System Manager Consultant

Consultys Suisse; Bern; Vor Ort; CHF 80’000 - 100’000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Quality System Manager Consultant to join their dynamic team. This role offers the opportunity to ensure compliance with ISO and GMP standards, providing critical support to operations and quality control teams. You will be responsible for auditing internal quality systems, overseeing compliance of change controls, and managing special QA projects. With a focus on teamwork and individual contribution, this is a chance to thrive in a human-sized company that values diversity and inclusion. If you have a strong background in quality assurance and are ready to make an impact, this position is perfect for you.

Qualifikationen

• 5-10 years of experience in Quality Assurance or aseptic processing.
• Knowledge of GMP compliance and ability to manage multiple projects.

Aufgaben

• Ensure compliance with ISO/cGMP quality system requirements.
• Audit internal quality systems and perform external audits of suppliers.

Kenntnisse

GMP compliance knowledge

Quality Assurance experience

Communication skills

Project management

Regulatory knowledge

Tools

Microsoft Office

Database management

Jobbeschreibung

Senior Quality System Manager Consultant

As part of our development, we are recruiting a Senior Quality System Manager Consultant to join our teams.

Responsibilities:

• Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to GMP Part 1 and 2 or the EU Guidelines to GMP Medicinal Products for Human and Veterinary Use.
• Provide immediate support to operations and quality control staff to address compliance related concerns.
• Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
• Audit internal quality system elements in manufacturing and operational support areas.
• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
• Perform external audits of suppliers/vendors/off-site facilities.
• Act as a customer interface during on-site audits, conference calls and other standard means of communication.
• Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
• Prioritize and manage a variety of projects simultaneously.
• May need to lead and direct the work of others. Review and approve validation documents.
• Review and Master Batch Records (MBR) and supporting documents.
• Perform review/release of batch records, as needed.

Your Profile:

• 5-10 Years Experience
• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
• GMP compliance and Part 11 compliance knowledge preferred.
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
• Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
• The ability to interface and communicate directly with clients is required.
• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.

Do you want to join the consulting world in a human-sized company that values the individual and performance?

To share your skills within a cohesive team where experiences are freely shared?

CONSULTYS is open to all talents and is committed to diversity and inclusion.

Seniority Level:

Associate

Employment Type:

Full-time

Job Function:

Quality Assurance

Industries:

Business Consulting and Services and Biotechnology Research