Lonza

QA Specialist, Batch Record Review 80-100% (f/m/d)

Lonza  •  Visp, CH (Hybrid)  •  1 day ago
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Job Description

Location: Visp, Hybrid Work Model. Relocation assistance is available for eligible candidates and their families, if needed.

The QA Specialist, Batch Record Review reports to the QA Operations Group Lead, working in close collaboration with different Quality and multiple Operations functions in order to ensure cGMP-compliant manufacturing activities and documentation within the organisation.

What you will get:

  • An agile career and dynamic working culture

  • A highly collaborative environment that fosters teamwork and inclusion

  • A range of professional development programs to grow your skills and career

  • An ethical workplace where tasks are carried out in accordance with relevant procedures

  • In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Benefits in Visp: https://bit.ly/3wjkoFi

What you will do:

  • Review of the Executed Batch Records (e.g. production documentation review, raw data etc)

  • Support batch release by ensuring the completeness of the documentation package

  • Review comments added to the Executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager

  • Support the initiation of deviations and investigations for Batch Record review related observations

  • Collect and evaluate on a regular basis KPI data

  • Write and revise SOPs in his/her area of expertise

What we are looking for:

  • Academic degree OR relevant work experience in Biology/ Chemistry/ Biotechnology or other related field

  • Previous experience in GMP regulated pharmaceutical / API industry is an advantage

  • Ability to identify non-compliance and gaps from quality standards

  • Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive

  • Fluent English (written and verbal) is required, German language skills preferred

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Lonza

About Lonza

Lonza is a pioneer and world leader in the CDMO industry, setting the pace with cutting-edge science, smart technology, and lean manufacturing. United by a common purpose, we turn our customers’ breakthrough innovations into viable therapies and manufacture the medicines of tomorrow.

Founded in Switzerland in 1897, our company is the first and original CDMO, and today we are more dynamic, agile and forward-focused than ever before. As one of the largest Western CDMOs, we bring together a global team of around 18,500 colleagues across five continents to deliver comprehensive, integrated solutions for our customers' complex needs.

For our customers and their patients, we bring quality, safety and reliability to bring life-enhancing and life-saving treatments to market at speed and at scale. For our colleagues, we strive to create a sense of belonging and inclusion where every person can thrive and bring their best.

Industry
Chemicals & Materials
Company Size
10,000+ employees
Headquarters
Basel, CH
Year Founded
1897
Website
lonza.com
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