Biologics QA (Contract)

Up to Swiss Franc74000 per annum
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Switzerland
Basel, Switzerland
Posting date: 07 Jun 2021
38062

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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