Senior QA Specialist - QA Projects 80-100% (f/m/d)

Lonza Group; Oberwallis; Remote; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Lonza seeks a Senior QA Specialist for QA Projects in Visp, Switzerland. You will specify quality requirements for manufacturing processes, ensuring product safety, quality and cGMP compliance across the product life cycle.

You will review records, manage deviations and change controls, interact with health authorities, and mentor junior staff while supporting cGMP training.

Qualifikationen

• GMP regulated pharma experience required, QA role preferred.
• Knowledge of biopharmaceutical manufacturing processes and analytical methods.
• Experience with health authorities (Swissmedic, FDA) interactions.
• Ability to manage projects and prioritize timelines in a fast-paced environment.
• Strong communication and teamwork skills.
• Business fluent English; German is a plus.

Aufgaben

• Own all quality responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply.
• Represent QA in project/tech transfer organizations for new biotech manufacturing processes.
• Review and release SOPs, Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports.
• Perform assessments for product-related changes and provide change controls for regulatory filings where required.
• Investigate deviations and customer complaints; document appropriately.
• Identify QA topics and contribute to Quality & Compliance strategies and standards.
• Train and mentor junior Lonza employees; support cGMP training.

Kenntnisse

GMP knowledge

QA experience

Regulatory interactions

Project management

English proficiency

Ausbildung

Science degree

Jobbeschreibung

Senior QA Specialist - QA Projects 80-100% (f/m/d)

Location: The actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

The role:

The Senior QA Specialist (f/m/d) for QA Projects specifies quality requirements for manufacturing processes and cGMP standards over their entire life cycle. As a Quality and Compliance representative he/she will be a key member in cross-functional project teams ensuring measures for product safety, product quality & cGMP compliance are implemented.

What you will get:

An agile career and dynamic working culture

An inclusive and ethical workplace

Compensation programs that recognize high performance

A variety of benefits dependant on role and location

Own all quality related responsibilities for the manufacturing processes of biopharmaceutical products for clinical and commercial supply. Represent QA in project/tech transfer organizations for new biotech manufacturing processes.

Responsible for review and final release of records like Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.

Perform assessments for all product-related changes, assesses relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required.

Ensure all deviations are appropriately investigated and recorded, direct the investigations of customer product complaints and assure the completion of the appropriate documentation.

Identifie emerging QA relevant topics, communicate to the IBEX QA organization and work actively on their development into new or already established Quality and Compliance strategies and/or standards.

Train and mentor junior Lonza employees to better accomplish and perform in their duties as Quality professionals. Support cGMP training programs to ensure staff is being trained.

What we are looking for:

Academic degree in Chemistry/ Biotechnology/ Life Science or any related field.

Solid experience in the GMP regulated pharmaceutical industry is required; preferably in a QA role.

General knowledge of biopharmaceutical manufacturing processes and analytical methods.

Experienced in the interaction with health authorities (Swissmedic, FDA etc.).

Ability to oversee project execution to identify non-compliance from quality standards. Ability to prioritize and manage work to critical project timelines in a fast-paced environment.

Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.

Strong team orientation with excellent verbal, written and interpersonal communication skills.

Business fluent English is required, good German skills - an advantage

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.