Biologics QA (Contract)
An exciting contract opportunity has arisen for for a Biologics Quality Assurance to join a dynamic and talented team in Switzerland. In this role you will support the manufacturing of clinical trials, from compliant production to preparations of documentation
- Receipt of goods, proper storage and preparation for shipment of goods.
- GMP compliant manufacturing of dosage forms including execution of required in-process controls and input into MES system / manufacturing & IPC.
- GMP compliant documentation and control of the performed activities (electronic batch documentation, logbooks, labels, forms, related inserts)
- Operation incl. setup, cleaning and disinfection of manufacturing equipment and rooms
- Assist in performing maintenance & calibration of manufacturing equipment and assist in assigned capital projects (e.g., as part of qualification and commissioning)
- Delegated sample train
- Proactively collaborate and share knowledge with team and project stakeholders; assist with onboarding of new colleagues in a mentoring role
- Contribute to the implementation and compliance of 5S and IQP/Continuous Improvement (CI) measures.
- Contribution of ideas for the suggestion scheme
- Collaborate in the preparation of internal and external audit & actively participate in the execution of audit
- Collaboration to fulfil the Supply Team specific KPI's
- Collaboration in the creation / revision of SOP's
- Adherence to assigned SOP's and training and timely completion in the training system.
- Compliance with cGMP, HSE, Data Integrity and ISEC (Information Security) guidelines.
- Adherence to Novartis values and behaviour
- Adherence & performance of various responsibilities as per respective responsibility lists.
Skills and Requirements
- Completed professional training.
- Vocational training as a chemical and pharmaceutical technologist, food processing or sanitation technician, or technical vocational training with experience in a GMP regulated environment
- Fluency in German (oral and written).
- Good command of English (oral and written).
- 5 years of experience in GMP regulated environment, unless specialised training as a chemical or pharmaceutical technologist.
- Experience in development operations of a pharmaceutical manufacturing facility desirable.
- Ability to work in a team, ability to work under pressure, willingness to work in full protective suit and personal protective equipment
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.