QA Operation

QA Operation

Gi Life Science is partnering with an international pharmaceutical company to find a QA Operations for a 4-month temporary mission.

Your mission:

Ensure compliance from raw material reception to drug release

Your Responsibilities:

• Ensure compliance of manufacturing processes, batch records, deviations, change control, and CAPA.
• Review and approve executed batch records within defined timelines.
• Responsible for technical batch release.
• Provide active on-the-floor support.
• Review and approve operational elements like procedures and related documents.
• Assist with continuous improvement initiatives.
• Supervise the preparation of the Annual Product Review (APQR) and ensure timely execution.
• Be present during critical manufacturing steps.
• Respect and share data integrity rules (ALCOA+).
• Propose improvements for flows, manufacturing activities, and organization.

Your profile:

• Master's degree or equivalent experience.
• 3-5 years in the pharmaceutical industry.
• min 1 year in commercial batch release.
• Knowledge of pharmaceutical manufacturing processes, especially biologic drug substances.
• Experience in SAP and electronic MES is an asset.
• Fluent in English.

Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360 .

jid6bffa4daen jit1044aen jpiy25aen