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Michael Page
Batch Record Review Specialist (m/f/d)Michael Page • Lucerne, CH
Batch Record Review Specialist (m/f/d)

Batch Record Review Specialist (m/f/d)

Michael Page • Lucerne, CH
Vor einem Tag
Stellenbeschreibung

The selected candidate focuses on right‑first‑time execution, documentation robustness, and efficient record lifecycle management across paper‑based batch records and Electronic Batch Records, by carrying out the following task area:

  • Reviews completed batch records for biologics manufacturing (upstream, downstream, weighing & dispensing, and solution prep) to ensure accuracy, data integrity (ALCOA+), and GDP compliance
  • Checks both paper and electronic records, including material tracking in SAP (COMET), and flag any gaps or inconsistencies
  • Identifies errors or missing information and work with manufacturing teams to fix them quickly, supporting "right first time" execution
  • Helps create, update, and maintain batch record templates, SOPs, work instructions, and forms in collaboration with cross-functional teams
  • Supports the rollout and use of updated documentation in manufacturing operations.
  • Assists with documentation-related deviations, corrections, and investigations by providing input and supporting records
  • Manages controlled copies of manufacturing documents and support GMP-compliant archiving, retention, and disposal
  • Ensures documents are traceable and properly version-controlled throughout their lifecycle

To be considered for this position, the ideal candidate must have:

  • Successfully completed bachelor's degree (or equivalent experience) in life sciences, biotechnology, engineering, or a related field, with experience in GMP and preferably clinical biologics manufacturing
  • Familiar with upstream and downstream processing, as well as weighing & dispensing and solution/media preparation, including related documentation
  • Hands-on experience with batch records (paper and/or electronic) and good understanding of GDP and GMP documentation practices
  • Experience with MES/EBR systems (e.g., PAS-X, Syncade) and tools like SAP is a plus.
  • Strong collaboration skills, able to work across teams such as Operations, Tech Transfer, MES, and Quality
  • Clear and effective technical writing skills, with the ability to prepare and review GMP documentation
  • Proactive and detail-oriented, with a focus on improving processes and ensuring robust operations
  • Strong communication skills in both German and English

Excellent project to join a well-known and prestigious pharmaceutical company with extension option.

Jobalert für diese Suche erstellen

Batch Record Review Specialist (m/f/d) • Lucerne, CH

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