Chemist Quality Assurance

Support the Sr. Manager QA in all quality related activities within a GMP-regulated environment. Ensure the timely review of batch documentation and associated analytical results, and perform the final status assignment or rejection of intermediate and finished products. Review, assess, and approve quality-related documents (e.g. manufacturing instructions, analytical procedures, validation and qualification documentation, and Certificates of Analysis (CoAs). Ensure compliance with applicable GMP requirements and actively contribute to the continuous improvement of the Quality Management System (QMS). Review and manage deviations, change controls, CAPAs, and customer complaints in accordance with internal procedures and regulatory requirements. Support the preparation, execution, and follow-up of customer, supplier, and regulatory authority audits. Plan, perform, and ensure the timely execution of environmental monitoring (re-) mapping studies, including the evaluation, documentation, and reporting of study results.

CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in St-Beauzire (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees.

• Degree in Chemistry, Pharmacy, Analytical Chemistry, Food Chemistry or a comparable scientific qualification

• Professional experience in Quality Control or Quality Assurance within the chemical or pharmaceutical industry

• Strong knowledge of organic preparative and/or analytical chemistry

• Solid understanding of GMP and ideally other quality systems such as ISO 9001 or GLP

• Experience in batch record review and handling quality-related documentation

• Proficient in MS Office; knowledge of LIMS, chromatography data systems and SAP/ERP is an advantage

• Very good German and good English communication skills, both written and spoken

• Independent, accurate and reliable working style with strong communication and teamwork skills