Quality Assurance Manager

vor 4 Wochen

Visp, Schweiz Lonza Vollzeit
About the Role

Lonza is a global leader in life sciences, operating across three continents. Our success is driven by talented individuals working together to devise innovative solutions that help businesses improve people's lives. In return, we empower our employees to own their careers, allowing them to genuinely make a positive impact on the world.

Key Responsibilities

As a Senior QA Manager, you will support our Drug Product Services (DPS) Organization in Visp, Switzerland. Your key responsibilities will include:

  • Representing Quality Assurance in cross-functional teams, establishing and maintaining interfaces with Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.

  • Assessing, reviewing, and approving quality records, such as deviations, change control, CAPAs, investigations, effectiveness checks, and extensions, in line with current local SOPs.

  • Authoring, reviewing, and approving GMP-relevant documents and SOPs.

  • Organizing DPS Quality Councils.

  • Presenting Drug Product QA topics during customer audits and regulatory inspections within DP.

  • Participating in internal audits as required by the organization.

Project-Specific QA Functions

As a Senior QA Manager, you will also be responsible for:

  • Acting as the point of contact for Drug Product QA-related questions and issues related to manufacturing operations.

  • Supporting and approving project / product-specific risk assessments.

  • Reviewing and releasing product-specific documentation, such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.

  • Reviewing and approving executive batch records, preparing batch release for the responsible person (FvP), including recommendation on disposition status.

Requirements

To be successful in this role, you will need:

  • A Bachelor, Master degree, or PhD in Biology, Chemistry, Biotechnology, Life Science, or a related field.

  • Significant work experience in a quality function within a GMP-regulated area.

  • Several years of experience in aseptic processing for Drug Product and associated installations, including:

    e.g. filling line / isolator / depyrogenation tunnel / lyophilizer/Media Fill / Aseptic Process Simulation

    Environmental Monitoring (microbiological background/experience) and associated Cleanroom classifications

    Requirements for Visual Inspection/Container Closure Integrity Testing CCIT of Drug Product

    Moist Heat & Dry Heat Sterilization e.g. autoclave / SIP sterilization-in-place, depyrogenation experience and biological challenge with BIs/endotoxin

  • Language skills: English is a must, German would be desired.

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