Specialist Product Quality

vor 1 Tag

Bern, Schweiz Randstad Vollzeit

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 400 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.

Aim of the position

  • Ensuring that products, materials for production, systems and facilities are in state of sustainable compliance with GMP requirements

  • Provide quality guidance to all departments on site for the different cGMP related subjects

  • Support the execution of health and non-health authorities inspections

    Main Responsibilities

    • Ensure the GMP-compliant production of active ingredients and drugs for clinical trials and commercial products

    • Contact person for production, development, and quality control for all product quality related topics

    • Ensure that deliverables assigned to Product Quality team as part of projects are successfully achieved on time

    • Review of Process Description and (electronic) master batch records (MBR)

    • Review of executed (electronic) batch records

    • Preparation for batch disposition

    • Release planning activities for manufactured products

    • Ensure the consistent quality of produced materials

    • QA oversight for aseptic processing

    • Review and approval of non-conformities, and Change Controls

    • Ensure the relevancy and effectiveness of corrective and preventive actions

    • Review and approval of Standard Operating Procedures, Work Instructions and Risk Assessments

    • Support Annual Product Review

    • LIMS profiles approval for produced materials and stability studies

    • SAP Set up for produced material

      qualifications

      Who we are looking for

      • University degree in pharmacy, natural science, medicine or equivalent

      • Minimum 2 years of working experience in a GMP related environment, preferable in Quality

      • Knowledge of electronic Batch Record Review

      • Strong knowledge of GMP requirements for commercialized, development and clinical products

      • Good leadership capabilities

      • Strong communication and team-work skills

      • Strong assertiveness

      • Proactive attitude, challenging the status quo, decision maker

      • Cultural sensitivity

      • Ability to work in a diverse and changing environment

      • Flexibility, accuracy and reliability

      • Ability to prioritize and to continuously review priorities

        This job is based in Bern, Switzerland and will initially be limited to 12 months. If you are interested in working for a global leading health care company, in a highly dynamic and flexible work environment, then send us your application today. Or give us a call if you have any questions

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