quality assurance specialist (capex projects) // johnson & johnson in Bern

posted
contact
Stephan Zoebeli, Randstad JnJ Bern
job type
temporary
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job details

posted
location
bern
sector
life sciences
job type
temporary
reference number
127140-308
contact
stephan zoebeli, randstad jnj bern
phone
058 231 57 94

job description

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 265 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Janssen Vaccines belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 350 people of over 20 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products and therapies.

Main Responsibilities:

  • Ensuring that applicable GMP requirements for equipment, rooms, systems, and utilities' design and qualification / validation are met within CapEx projects
  • On time review of calibration, maintenance and change notifications' related documentation
  • On time review and approval of qualification and validation documentation
  • Technical Services Contact person for C&Q for all equipment / systems / utilities related topics
  • Ensuring that Q Ops activities required for new product introduction of product commercialization are performed on time ? Planning of the relevant activities
  • Supporting Operations in ensuring that a product is ready for being manufactured under GMP conditions (GMP readiness)
  • Supporting GMP-compliant production of active ingredients and drugs for clinical trials and market launch
  • Reviewing and approving non-conformances, CAPAs, and Change Controls
  • Ensuring the relevancy and effectiveness of corrective and preventive actions
  • Support the collection of KPIs to measure Quality and Operations' performance
  • Writing, review and approval of process documents (e.g. SOPs, work instructions, job aids, process descriptions, etc.) and risk assessments
  • Supporting internal and external audits
  • Supporting the execution for risk management activities for the site

qualification

Who we are looking for:

  • University degree in pharmacy, natural science, medicine, or equivalent
  • Work experience in Quality department in pharmaceuticals, biotechnologies or chemistry industry
  • Good communication skills in both German and English language
  • Excellent communication and teamwork skills
  • Ability to work in a diverse and changing environment
  • Flexibility, accuracy and reliability
  • Ability to prioritize and to continuously review priorities

This job based in Bern, Switzerland will initially be limited to December 2021 with extension possibilities. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!