Quality Assurance Expert(m/w/x)

# Quality Assurance Expert Full time CHE - Neuchatel, Switzerland ## **Job Description** # **About the job** **:** Takeda’s Neuchatel Quality department is looking for a highly motivated **Quality Assurance Expert** to join the team dedicated to providing quality oversight for operational activities related to **Bulk Drug Substances** manufacturing activities of biologic products. This is an exciting career opportunity for a dynamic, autonomous, rigorous and change agile quality professional to embrace a team\-based culture in a world\-class Biotech manufacturing environment. As QA Expert you will report directly to the QA Manager and be responsible for compliance and quality oversight related to activities throughout the manufacturing and certification process. The QA Expert is the representative for both routine GMP (Good Manufacturing Practices) activities as well as for improvement initiatives for his/her department. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements. Participation in GMP zone audits as well as internal and external regulatory inspection is an integral part of his/her activities. The QA expert is accountable for the promotion of continuous improvement and involved related initiatives. # **How you will contribute** **:** * Provide support and guidance to production team units in their routine activities directly on the floor, fostering application of cGMP concepts. * Lead and/or review deviations in the framework of production events within quality systems (i.e., Trackwise) 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 CAPA. * Evaluate internal and/or external change requests and follow deployment through change control according to procedures, GMP requirements and regulatory licenses. * Prepare, evaluate, and approve controlled documentation revision. * Contribute to the batch certification of Bulk Drug Substances. * On\-call duty quality support for manufacturing activities. * Participate and/or lead improvement initiatives and enhancement projects. * Perform internal facility GMP audits of manufacturing and support areas. * Participate in external regulatory agency inspections, observation responses and regulatory submission preparation as required. * Participate in day\-to\-day operational decisions as needed. * Report out of findings/issues to functional leaders and higher management as needed. # **What you bring to Takeda** **:** * Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy or “Quality Management” applied to industrial process. * 2\-5 years of experience within a GMP environment, biotech/pharmaceutical company. * Knowledge in Computer System Validation, electronic Batch Record and Digitalization is a plus (Manufacturing, Engineering, Quality). * Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, Quality system standards and data integrity principles. * Knowledge in auditing and inspection against regulatory / quality standards. * Knowledge and interest in detailed manufacturing operations (e.g., engineering designs, automation documentation, biotechnological processes). * Autonomous, structured, rigorous and self\-motivated. * Solution oriented, pragmatic, ability to simplify complexity. * Able to manage priorities in a fast and dynamic environment with a strong emphasis on maintaining high quality standards. * Team player, prepared to work in team\-based culture including manufacturing personnel on the floor. * Demonstrate excellent communication skills (oral and written), ability to adapt to audience. * Oral and written skills in English and French, fluency is an asset. # **What Takeda offers you** **:** * Competitive salaries. * Full accident coverage. * Participation in health insurance premiums. * Advantageous pension plans. * Subsidised meals. * Financial participation in employee sports activities. * Transport: support for local public transport passes, free parking, car sharing programme. * Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well\-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies. * Takeda Neuchâtel is an employer committed to its employees and to future generations. # **“Empowering our people to shine” :** *Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and job applicants without regard to skin colour, religion, gender, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law**.* ## **Locations** CHE \- Neuchatel ## **Worker Type** Employee ## **Worker Sub\-Type** Regular ## **Time Type** Full time