Senior QA Expert (m/w/d)

About

This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department. Within this position, QA Expert is responsible for compliance and quality oversight related to activities throughout the manufacturing and release process of bulk drug substance.

Tasks

• Inspection and Release of raw material and external BDS
• Participate to the feeding of the KPI of release of raw materials
• Prepare, evaluate and approve new or revised controlled documents (procedures, SOPs, forms, SISA, specifications, etc.)
• Ensure timely review and implementation of documentation for accuracy and compliance
• Propose continuous improvement of documents in direct partnership with relevant SME
• Lead or review and approve deviations in the framework of production and laboratory events within quality systems to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant corrective/preventive actions (CAPA)
• Ensure deviation and CAPA management documentation in a timely manner
• Develop and implement appropriate tools and methods to perform standard investigation and problem solving techniques, to close exception documents, and to ensure appropriate adherence to quality documents (procedure, run sheets, material specification, etc.)
• Evaluate internal and/or external change requests and follow deployment through change control according to procedures, GMP requirements and regulatory licenses
• Act as change approver for routine and emergency chnges. This includes performing evaluation, assist, review and prepare corresponding documentation until timely closure of all tasks and change control records
• Provide quality oversight, i.e. support and guidance to production team units in their routine activities directly on the floor, fostering strict application of cGMP concepts and quality systems
• Participate in day-to-day operational decisions as needed, including on-call service
• Report any potential issue detected on the floor and proposes adequate guidance for documentation and correction
• Establish efficient partnership with production and associate departements (e.g: maintenance, engineering, QC, etc-) to define and review detailed action plan for any process modification or improvement
• Participate and/or lead meetings with production and other departments as approriate
• Ensuire respect and commitment to EHS guidelines

Requirements

Start: 01.05.2026