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Batch Record Reviewer 60%(m/w/x)

Lonza
Visp

You ensure the accuracy and compliance of batch records by reviewing documentation, verifying data, and collaborating with various teams to resolve discrepancies and support investigations.

Anforderungen

  • •Completed vocational training in pharmaceuticals
  • •Experience in sterile drug product is advantageous
  • •Proven understanding of cGMP regulations
  • •Proficient in MS Office and IT systems
  • •Structured and precise working style
  • •Ability to organize tasks independently
  • •Strong communication skills and teamwork
  • •Ability to identify non-compliance gaps
  • •Experience collaborating with different functions
  • •Fluency in English and B1 German skills

Deine Aufgaben

  • •Review executed batch records and logs.
  • •Verify process data using LIMS and SAP.
  • •Clarify comments on batch records with operations.
  • •Support initiation of deviations and investigations.
  • •Revise SOPs, forms, and logbooks.
  • •Independently review batch records for compliance.
  • •Lead real-time review during batch execution.
  • •Collaborate with cross-functional teams to resolve discrepancies.

Original Beschreibung

# Batch Record Reviewer 60% (f/m/d) **CH - Visp** | **Part time** For our site in Visp we are looking for a dedicated Batch Record Reviewer 60%(f/m/d) to extend our team. If you are passionate about applying your expertise to optimize drug product manufacturing and truly make a difference, we encourage you to explore this opportunity. **Key responsibilities:** - Review of the Executed Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures, raw data, logbooks) - Verified and cross-checked process data using LIMS (material release, expiry dates, test results), SAP, and DMS (for special release documentation), ensuring accurate reporting across systems - 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 - Revise SOPs, forms and logbooks in area of expertise - Independently review the driven batch records in both paper (MBR, forms, protocols, equipment reports, logbooks) and electronic formats (MES), ensuring data integrity and compliance with GMP - Leading all aspects of the completion during the batch execution (real time review) in terms of GDocP and ALCOA principles to reduce the review time Collaborated closely with cross-functional teams including Process Experts, MSATs, and QA to resolve discrepancies and ensure clarity in manufacturing records. **Key requirements:** - Completed vocational training and experience in a pharmaceutical environment preferably in sterile drug product is advantageous - Proven understanding of current cGMP regulations - Proficient in MS Office and other relevant IT systems - Structured and precise working style according to defined procedures - Ability to organize tasks independently and ensure timely completion - Strong communication skills, teamwork, and flexibility - Ability to identify non-compliance and gaps from quality standards - Experience collaborating closely with different functions and departments - Fluency in English language (written and spoken) and B1 (intermediate) -German language skills are an asset Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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