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

Job Responsibilities

• 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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