Senior QA Specialist, QA Operations

Vor 7 Tagen

Visp, Schweiz Lonza Vollzeit

Today, Lonza stands out as a prominent player in the field of life sciences with operations spanning three continents. In our scientific endeavors, there's no secret recipe; it's all about talented individuals collaborating, brainstorming innovative concepts that drive business to benefit society. We empower our team to steer their own career paths, fostering a culture where both big and small ideas genuinely enhance the global landscape. This is the kind of impactful work that resonates with us.

As our site in Visp, Switzerland expands, we are seeking a Senior QA Specialist for Large Scale Mammalian operations within Ibex Solutions, our groundbreaking biological manufacturing and development initiative. In this role, you will oversee QA Operations, engaging closely with key stakeholders in the Operations Team, QA/QC, and Project Management branches.

Key responsibilities:

  • Act as QA Ops cleaning Subject Matter Expert (SME) in interactions with relevant stakeholders and customers, as well as during audits and inspections
  • Review and approve routine cleaning-related documentation, such as routine cleaning plans, reports, MAC plans, and cleaning QC plans
  • Take ownership of all quality tasks related to cleaning and manufacturing processes of biopharmaceutical products, and serve as the QA representative in project/tech transfer teams
  • Review and finalize records including Standard Operating Procedures (SOPs), Master Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports, among others
  • Identify emerging QA-focused themes, communicate them to relevant stakeholders, and actively contribute to shaping them into fresh Quality and Compliance strategies or standards, like CAPAs
  • Assist in batch disposition preparation, providing recommendations on disposition status
  • Support continual enhancement initiatives to establish efficient Quality Management Systems

Key requirements:

  • Bachelor's or Master's degree in chemistry, biotechnology, life science, or related field
  • Substantial experience in the GMP-regulated pharmaceutical arena, with a preference for prior QA involvement
  • We are seeking an independent, sociable individual with a customer-centric approach, valuing teamwork
  • General familiarity with manufacturing processes, cleaning techniques, and analytical methodologies
  • Proficiency in TrackWise, SAP, and Microsoft Office software is advantageous
  • Exposure to engaging with health authorities (Swissmedic, FDA, etc.) is a plus
  • Fluency in English, with the ability to communicate in German or a willingness to learn

Lonza's products and services touch the lives of millions every day, a responsibility we hold with utmost reverence. The means by which we attain our business objectives is as significant as the accomplishments themselves. At Lonza, we prioritize the well-being of our personnel and the environment. Any triumph we achieve holds no value if not attained ethically.

Individuals flock to Lonza for the thrill and ingenuity of tackling complex challenges and pioneering new concepts in life sciences. In return, we offer the gratification that comes with enhancing lives across the globe, effecting a meaningful change.

Reference: R60324

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