Batch Record Review Specialist (m/f/d)

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.