Senior QA Automation Specialist, EBR

Senior QA Automation Specialist, EBR

Lonza

Visp, Switzerland

What you'll do:

• Partner with internal customers for quality topics linked to the set-up of eBR (electronic batch records) within the project.
• Check and approve master production records and electronic master batch records (EMBR) for consistency with approval documents, process descriptions, transfer documents, test plans, and parameter lists.
• Review completed batch records within the specified timeframe.
• Review minor deviations, investigations, and CAPAs within the defined due dates.
• Ensure that batch records are closed and archived when all batch-related activities are completed.
• Assist in managing and tracking performance metrics and quality data, supporting QA department in various meetings.
• Take on other tasks as assigned, ensuring seamless operations.

What we're looking for:

• Academic degree in Chemistry/Biotechnology/Life Sciences or any related field is preferred, with equivalent experience considered.
• Solid experience in the GMP-regulated pharmaceutical/API industry is required.
• Experience in electronic batch records (execution and/or review) is preferred.
• Ability to recognize non-compliance and gaps in quality standards.
• Structured, detailed, and well-organized work attitude; open-minded to new ideas and suggestions; agile, highly motivated, and dynamic.
• Business fluent English is required, good German language skills - an advantage.

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