Quality Assurance Specialist // Johnson & Johnson in Schaffhausen

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, that 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 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

With a workforce of roughly 1,200 people, Cilag AG is one of the major producers of the Swiss pharmaceutical industry and one of the most important employers in the Schaffhausen region. Set up in 1936, the company has been a member of the Janssen Pharmaceutical Companies of Johnson & Johnson since 1959. Cilag AG is a centre for launching and boosting growth in parenterals. The company produces high-quality pharmaceutical substances and products, from which patients benefit all over the world.

Main Responsibilities

• Review, analyze, coordinate and/or investigate assigned customer complaints; consisting in proper documentation, inspection of product returns, investigation technical details, root cause analysis, risk assessment, and assist/lead associated CAPA investigations
• Ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications
• Develop a thorough understanding of the complaint database, and products in scope of the site
• Assess of market impact of a complaint and escalate critical issues for proper disposition as necessary
• Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
• Support internal, external, and third-party audits
• Support additional project team activities and/or investigations, and participate in process improvement activities and projects

Who we are looking for

• Bachelor or Master Degree in engineering, physical, biological, natural sciences or other related field is required
• Work experience in quality in a pharma/medical device or other regulated industry is required (Previous experience with complaints handling is preferred)
• Investigative & analytical critical thinking skills
• Experience with CAPA root cause investigation execution, implementation of corrective and preventive actions to improve quality processes is highly preferred
• Strong decision-making skills, able to make sound business decisions with sometimes limited information
• Strong written and verbal communication skills in English

This job based in Schaffhausen, Switzerland will initially be limited to approx. 18 months. 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!