Job speichern Zurück zu Suche Stellenbeschreibung Übersicht Ähnliche Jobs hinzugefügt 06/05/2026An innovative company with a global presenceProven track record in batch record reviewFirmenprofilFor 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.StellenbeschreibungThe 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 complianceChecks both paper and electronic records, including material tracking in SAP (COMET), and flag any gaps or inconsistenciesIdentifies errors or missing information and work with manufacturing teams to fix them quickly, supporting "right first time" executionHelps create, update, and maintain batch record templates, SOPs, work instructions, and forms in collaboration with cross-functional teamsSupports the rollout and use of updated documentation in manufacturing operations.Assists with documentation-related deviations, corrections, and investigations by providing input and supporting recordsManages controlled copies of manufacturing documents and support GMP-compliant archiving, retention, and disposalEnsures documents are traceable and properly version-controlled throughout their lifecycleAnforderungsprofilTo 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 manufacturingFamiliar with upstream and downstream processing, as well as weighing & dispensing and solution/media preparation, including related documentationHands-on experience with batch records (paper and/or electronic) and good understanding of GDP and GMP documentation practicesExperience 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 QualityClear and effective technical writing skills, with the ability to prepare and review GMP documentationProactive and detail-oriented, with a focus on improving processes and ensuring robust operationsStrong communication skills in both German and EnglishSonstige InformationenExcellent project to join a well-known and prestigious pharmaceutical company with extension option.Referenznummer angebenJN-052026-7011159ZusammenfassungBerufsfeldEngineering & ProduktionNäheres BerufsfeldQualität, TechnikBrancheHealthcare / PharmaceuticalOrtLuzernVertragsartInterimReferenznummerJN-052026-7011159
