Quality Specialist

Quality Specialist - Bern

Looking for graduate with 2 years of experience - Degree in pharmacy, natural science, medicine, or equivalent

GMP / Quality / CAPA

Caring for the world ? one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, which is anchored in the internationally applicable Credo. 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.

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

• 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

• Supporting the collection of KPIs to measure Quality and Operations? performance

• Writing, reviewing and approving 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

Who we are looking for:

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

  
  

• At least 1 year of working 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,

Thank you very much and we look forward to receiving your application.

Inclusion & Diversity

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!