Batch Record Reviewer

Lonza

Oberwallis

On-site

Vertraulich

Full time

9 days ago

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Benefits offered by this job

Site-based role in Visp
Dynamic working culture
Inclusive workplace

Job summary

Lonza in Visp, Switzerland, is seeking a Batch Record Reviewer to ensure flawless compliance, data integrity, and operational excellence in critical production projects. The role is fully site-based, enabling real-time collaboration and precise manufacturing.

You will review batch records, collaborate with Manufacturing and Quality, and analyze records in MES Syncade, DeltaV, TrackWise, SAP, and LIMS to uphold GDP and ALCOA+ standards.

Qualifications

  • GMP knowledge and exposure to a GMP-regulated manufacturing or QA environment.
  • Strong understanding of GDP and ALCOA+ data integrity principles.
  • Hands-on with electronic batch records and quality management systems.

Responsibilities

  • Ensure timely release and compliance of medicines by performing batch record reviews.
  • Collaborate with Manufacturing and Quality to investigate batch discrepancies.
  • Analyze electronic and paper batch records across MES/ERP/LIMS systems.
  • Evaluate process parameter failures and material usage with GDP/ALCOA+ guidance.
  • Draft clear quality impact statements and post-production documentation.
  • Drive continuous improvement and data integrity across site production lines.

Skills

GMP knowledge
GDP/ALCOA+ data integrity
Problem solving
Independent worker
English fluency

Education

Degree in Life Sciences/Biology/related field

Tools

MES Syncade
DeltaV
TrackWise
SAP
LIMS

Job description

Are you looking to make a direct impact on the delivery of life‑saving medicines? Join our dynamic Quality Assurance team in Visp as a Batch Record Reviewer, where you will ensure flawless compliance, data integrity, and operational excellence across critical production projects.

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:
  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
What you will do:
  • Ensure the timely release and compliance of life‑saving medicines by performing rigorous batch record reviews.
  • Partner with cross‑functional teams, including Manufacturing and Quality, to investigate and resolve batch discrepancies.
  • Analyze electronic and paper‑based batch records within state‑of‑the‑art MES (Syncade), DeltaV, SAP, TrackWise, and LIMS environments.
  • Evaluate process parameter failures, material consumption, and operator comments in strict alignment with ALCOA+ and GDP principles.
  • Draft clear, compliant quality impact statements and author post‑production lifecycle documentation.
  • Drive continuous improvement and data integrity standards across site production lines.
What we are looking for:
  • Degree in Life Sciences, Biotechnology, or a related scientific discipline (or equivalent practical experience).
  • Proven track record working within a GMP‑regulated manufacturing or quality assurance environment.
  • Hands‑on experience with electronic batch record systems (MES Syncade, DeltaV) and quality management systems (TrackWise, SAP, LIMS).
  • Solid understanding of Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
  • Strong problem‑solving mindset with the ability to work independently and meet strict production deadlines.
  • Fluency in English (written and spoken) is required; German reading proficiency is a strong advantage.
About Lonza

At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow.

Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work they want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table.

At Lonza, they value diversity and are committed to creating an inclusive environment. As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role. Ready to play your part in shaping the future of life sciences?

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