QA Specialist (Bioconjugates)

QA Specialist (Bioconjugates)

Lonza

Visp, Switzerland

The site in Visp, Switzerland is growing and for our Biologics Quality organization, we are currently looking for a Senior QA Specialist for the Bioconjugates plant. The successful candidate will be responsible for QA Operations and will be in direct contact with the key stakeholders in the operations Team, QA/QC & Project Management teams within the organization.

Key responsibilities:

• Act as QA Ops cleaning SME in meetings with the relevant stakeholders, and customers, in audits and inspections.
• Reviewing and approving the routine cleaning-relevant documents, i.e., routine cleaning plans and reports, MAC plans and cleaning QC plans.
• Owning all quality-related responsibilities for the cleaning and manufacturing processes of biopharmaceutical products and representing QA in project/tech transfer teams.
• Responsibility for the review and final release of records like Standard Operating Procedures (SOPs), Master Batch Records, Material Specifications, Deviations, Change Requests, Effectiveness Checks, Testing Protocols & Reports etc.
• Identifying emerging QA relevant topics, communicating to the relevant stakeholders and working actively on their development into new or already established Quality and Compliance strategies and/or standards i.e., CAPAs.
• Supporting the batch disposition preparation, including recommendations on disposition status.
• Support continuous improvement programs to establish effective Quality Management Systems.

Key requirements:

• Bachelor or Master's degree in chemistry, biotechnology, life science or related field.
• Significant experience in the GMP-regulated pharmaceutical industry; preferably in a QA role is required.
• We are looking for someone who is independent, sociable, customer focused and who values working as a team player.
• General knowledge of manufacturing processes, cleaning procedures and analytical methods.
• Experience with TrackWise, SAP, and Microsoft Office software is preferred.
• Experience in the interaction with health authorities (Swissmedic, FDA etc.) is desired.
• Fluency in English, able to communicate in or willing to learn German.

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