Batch record reviewer (f/m/d) (80-100%)

For our site in Visp we are looking for a dedicated Batch Record Reviewer 80 - 100% (f/m/d) to extend our team.

Key Responsibilities

• Responsible for the planning, the execution and documentation of manufacturing campaigns for Drug Product in compliance to cGMPs, SOPs and applicable guidelines.
• Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements.
• Provides front line technical and procedural support, working with the manufacturing teams (operators), plant engineers and QA operations.
• Responsible to establish timely and with high quality the required production documentation (preparation and review of electronic batch records) or other relevant GMP documents for the assigned production area.
• Lead process related investigations and critical deviations and assists in decision making on production issues.
• Lead process changes, CAPAs, and CAPA effectiveness checks related to process within required timelines and through GMP systems (e.g. Trackwise, MES, training, etc.).
• Supports the execution of process validations, including planning and preparation of the required validation plans and reports, liaising with all the relevant parties at shopfloor to ensure accurate execution.
• Use scientific, process and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
• Be highly knowledgeable of product and process trends by providing input to Annual Product Reviews and Product Quality Review for analysis.
• Be a resource to other departments as Subject Matter Expert for the product and process knowledge.
• Provide training for assigned new processes and products.
• Acts as Subject Matter Expert during customer audits and visits, maintain their processes at inspection readiness level and to provide the necessary support.
• Responsible to prepare and execute SHE, EM and operation risk analysis for the assigned products and the implementation and control of defined measures.
• Executes innovation and improvement projects comprising general manufacturing aspects for the production plant.

Key Requirements

• Bachelor / Master Degree. Preferred area of study: Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
• Experience in Sterile Manufacturing on the shopfloor and/or QC/QA in an asset.
• Fluent in both German and English.
• Familiarity with GMP requirements, quality procedures and SOP execution.
• Strong leadership skills and team orientation.
• Good communication skills and interaction with a variety of interfaces within the organization and on the shopfloor.
• Structured, focused and well‑organized working attitude; open‑minded for new ideas and suggestions.
• High motivation and dynamic drive; solution‑oriented.
• Proven IT knowledge, knowledge in ERP (SAP) or MES (Syncade) is an asset.
• Prepared to work flexible working hours.