Senior Quality Assurance Professional

Vor 2 Tagen

Visp, Schweiz Lonza Vollzeit

Company Overview

Lonza is a global leader in life sciences operating across three continents.

We work in science, but there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses improve lives.

In exchange, we let our people own their careers. Their ideas genuinely improve the world and make a meaningful difference.

Job Description

This exciting opportunity involves joining our team as a QA Operations Senior QA Specialist (f/m/d).

The Senior QA will be a member of QA Operations for Mammalian Small Scale Drug Substance manufacturing.

Key responsibilities include:

  • Managing quality oversight for contamination control and gap evaluation for internal/ external audit/ inspections.
  • Providing quality oversight regarding contamination prevention risks and controls.
  • Leading CCS-related topics for the asset (Bioburden control strategy, hygiene, environmental monitoring).
  • Reviewing and approving deviation/ investigation related to environmental monitoring excursions in the production area.
  • Managing risk and quality oversight for CCS related topic.
  • Participating in the Global Microbial Contamination Control Community to exchange information and best practices.
  • Performing gap assessment for internal/ external audit and inspections.
  • Facilitating discussion within internal cross-functional teams (MSAT, Operations, QC etc).
  • Reviewing and approving the Standard Operating Procedure (SOP) of the relevant topic associated with the role.
  • Involved in customer audits as well as regulatory inspections and supports all activities to ensure inspection readiness of the department.

Salary

The estimated salary for this position is $120,000 - $160,000 per year, based on industry standards and qualifications.

Required Skills and Qualifications

To succeed in this role, you'll need:

  • Bachelor, Master's degree or PhD in chemistry, biotechnology, life science, or related field.
  • Sound years of experience in the GMP area within a pharmaceutical industry (preferably in the mammalian drug substance environment).
  • Good knowledge of GMP and regulatory requirements.
  • Strong leadership skills; very good communication skills and interaction with all kinds of interfaces within the organization.
  • Structured, focused and well-organized working attitude; open-minded to new ideas, agile, highly motivated, and solution-oriented.

Location

This role is located at Lonza's facility.

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