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 areas:
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 flags any gaps or inconsistencies
Identifies errors or missing information and works 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 supports 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 a 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
What's on Offer
Excellent project to join a well‑known and prestigious pharmaceutical company with option for extension
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