Senior QA Specialist: GMP & Tech Transfer Lead

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

An agile career and a dynamic work-ch

An inclusive and ethical workplace

Compensation programs that recognize高性

Zusammenfassung

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist (m/f/d) to join the Quality Operations team. You will ensure quality assurance across QA tasks during the transition to commercial production, collaborating with QC, Development and Manufacturing to meet project priorities.

You will review GMP records, support SOPs, and make on-the-floor decisions to maintain cGMP standards. Fluency in English and experience in pharma QA are essential.

Qualifikationen

• Academic degree in Life Sciences or a related field.
• Significant experience in the pharmaceutical Quality area.
• Work experience in Quality Assurance, Production or Engineering in pharma with cGMP.
• QA experience in tech transfer is preferred.
• Excellent knowledge of computer systems (e.g. TW, SAP) and quality tools.
• Fluent English (written & verbal) is required.

Aufgaben

• Take responsibility for specific QA operations tasks during the transition from current clinical production to commercial production
• Assess and manage tasks impacting Quality operation during GMP manufacturing
• Plan for future activities and coordinate with other departments (e.g. QC, Engineering, Manufacturing) to complete planned activities
• Support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a GMP manufacturing facility
• Review GMP records to ensure compliance with cGMP per written procedures
• Make real-time decisions on process events on the floor, based on SOPs & policies
• Participate in walkthroughs and audit/inspections

Kenntnisse

Quality Assurance experience

GMP knowledge

Ausbildung

Bachelor's degree in Life Sciences

Tools

TW

SAP

Jobbeschreibung

Lonza in Visp, Switzerland, is seeking a Senior QA Specialist (m/f/d) to join the Quality Operations team. You will ensure quality assurance across QA tasks during the transition to commercial production, collaborating with QC, Development and Manufacturing to meet project priorities.

You will review GMP records, support SOPs, and make on-the-floor decisions to maintain cGMP standards. Fluency in English and experience in pharma QA are essential.