Ph3About Our Client /h3 pFor 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. /p pThis position is available immediately for an initial 12-month contract, with the possibility of extension based on performance and motivation. /p h3Job Description /h3 pThe 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: /p ul liReviews completed batch records for biologics manufacturing (upstream, downstream, weighing dispensing, and solution prep) to ensure accuracy, data integrity (ALCOA+), and GDP compliance /li liChecks both paper and electronic records, including material tracking in SAP (COMET), and flags any gaps or inconsistencies /li liIdentifies errors or missing information and works with manufacturing teams to fix them quickly, supporting "right first time" execution /li liHelps create, update, and maintain batch record templates, SOPs, work instructions, and forms in collaboration with cross‑functional teams /li liSupports the rollout and use of updated documentation in manufacturing operations /li liAssists with documentation‑related deviations, corrections, and investigations by providing input and supporting records /li liManages controlled copies of manufacturing documents and supports GMP‑compliant archiving, retention, and disposal /li liEnsures documents are traceable and properly version‑controlled throughout their lifecycle /li /ul h3The Successful Applicant /h3 pTo be considered for this position, the ideal candidate must have: /p ul liSuccessfully 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 /li liFamiliar with upstream and downstream processing, as well as weighing dispensing and solution/media preparation, including related documentation /li liHands‑on experience with batch records (paper and/or electronic) and a good understanding of GDP and GMP documentation practices /li liExperience with MES/EBR systems (e.g., PAS‑X, Syncade) and tools like SAP is a plus /li liStrong collaboration skills, able to work across teams such as Operations, Tech Transfer, MES, and Quality /li liClear and effective technical writing skills, with the ability to prepare and review GMP documentation h3What's on Offer /h3 pExcellent project to join a well‑known and prestigious pharmaceutical company with option for extension /p /li /ul /p #J-18808-Ljbffr