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

Lonza; Schweiz; Presencial; Vertraulich; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Agile culture

Inclusive workplace

Performance rewards

Benefits vary by role

Resumo da oferta

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist for QA Projects to define quality requirements across biopharma manufacturing life cycles and ensure cGMP compliance in cross-functional teams.

You will own quality responsibilities for manufacturing processes, review records, and assess changes with change controls for regulatory filings where required, ensuring product safety and quality. This role is based in Visp and supports commercial and clinical supply.

Responsabilidades

• 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 SOPs, Master Manufacturing Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Perform assessments for all product-related changes, assess relevance to regulatory filings, decide to implement and provide change controls for approval to customers where required.

Descrição da oferta de emprego

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

The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits .

What you will do:

• 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.}