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Batch Record Review Specialist (m/f/d)

Lucerne Interim View Job Description
For our client, a leading international pharmaceutical company with modern offices in the canton of Lucerne, we are seeking a Batch Record Review Specialist (m/f/d). In this role, you will support clinical biologics manufacturing by reviewing completed batch records and ensuring all documentation meets ALCOA+ and GMP standards.

Added 06/05/2026

  • An innovative company with a global presence
  • Proven track record in batch record review

About Our Client

For our client, a leading international pharmaceutical company with modern offices in the canton of Lucerne, we are seeking a Batch Record Review Specialist (m/f/d). In this role, you will support clinical biologics manufacturing by reviewing completed batch records and ensuring all documentation meets ALCOA+ and GMP standards.

This position is available immediately for an initial 12-month contract, with the possibility of extension based on performance and motivation.

Job Description

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

The Successful Applicant

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

What's on Offer

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

Quote job ref
JN-052026-7011159

Job summary

Job Function
Engineering & Manufacturing
Specialisation
Quality
Industry
Healthcare / Pharmaceutical
Location
Lucerne
Contract Type
Interim
Job Reference
JN-052026-7011159

PageGroup is an equal opportunity employer committed to workforce diversity, both as an employer as well as a recruitment service provider. Each recruitment decision we make for people we hire and people we place into new roles is based solely on the candidates’ knowledge, experience and skills.