QA Specialist, CSV & Automation

Experis Schweiz; Oberwallis; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Lonza seeks a QA Specialist, CSV & Automation to support large-scale CAPEX projects within a GMP manufacturing environment. The role ensures qualification and validation of equipment and computerized systems used in aseptic facilities, from ideation through execution.

You will lead QA activities for CQV/CSV documents, approve protocols and reports, manage deviations and CAPAs, and provide cross-functional QA support across global projects. Fluent English is required; German is a plus.

Qualifikationen

• Bachelor's or Master's degree in Engineering, Life Sciences or related field.
• Significant GMP experience in a QA role for CSV/Automation of GMP systems.
• Experience with aseptic fill-finish processes and associated facilities is preferred.
• Fluent in English; German is advantageous.

Aufgaben

• Qualify/validate equipment and computerized systems per GMP policies.
• Approve SOPs, CQV/CSV documents, and related reports.
• Provide QA leadership and vendor qualification oversight for ongoing projects.
• Act as contact point for lifecycle/compliance of qualification/validation.
• Manage deviations, changes and CAPAs with timely resolution.

Kenntnisse

QA

CSV & Automation

CAPA management

Documentation

Leadership

Cross-functional collaboration

Ausbildung

Bachelor's or Master's in Engineering/Life Sciences

Tools

Kneat

TrackWise

DMS

Unifier

Jobbeschreibung

For our pharmaceutical client based in Visp, we are currently seeking an experienced QA Specialist, CSV & Automation to support large-scale CAPEX projects within a GMP-regulated manufacturing environment.

Description

The “QA Specialist, CSV & Automation” is responsible for the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment and utilities related to the GMP manufacturing of drug products as part of Lonza CAPEX project portfolio in Stein, AG. Responsible for the compliance of commissioning and qualification of large CAPEX projects (e.g. new drug product facility) from ideation to execution phases, throughout all design phases:

• ensures that qualification/validation plan and execution of equipment, infrastructure and computerized-systems are in place by adhering to Lonza Quality policies
• approves SOPs, commissioning/qualification/validation protocols and reports as well as project related CQV / CSV documents (e.g. URS, FAT/SAT, etc.)
• provides QA leadership, oversight and support to staff on qualification/validation topics related to ongoing projects and ensures that selected vendors are qualified
• acts as first point of contact within GQE for any area related to the lifecycle and compliance for equipment, infrastructure and computerized-systems qualification/validation, including documentation in shared global systems (e.g. Kneat, Trackwise, DMS, Unifier, etc.)
• Manages Quality deviations, changes and CAPAs/tasks in an open and timely manner, taking leadership for their resolution, but escalating when necessary

Key requirements

• Bachelor or Master's degree in Engineering, Life Sciences or related field
• Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
• Experience in a QA role for the CSV / Automation of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)

Fluent in English, German would be an advantage