Batch Record Reviewer

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.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

• 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 ERFP (SAP) or MES (Syncade) is an asset.

• Prepared to work flexible working hours.