QA Pharma Complaint Specialist (f/m/d) // Johnson & Johnson

☞ Randstad Switzerland

Ver: 128

Dia de atualização: 21-03-2024

Localização: Schaffhausen Schaffhausen SH

Categoria: Segurança de qualidade / Controle de qualidade

Indústria: Staffing Recruiting Biotechnology Research Pharmaceutical Manufacturing

Posição: Entry level

Tipo de empregos: Full-time

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Conteúdo do emprego

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.

The QA Complaint Specialist performs quality activities in support of new and existing products. The position has a great deal of interaction with many internal departments, including Engineering, Manufacturing, Purchase, Quality Control, and global Stakeholders. The QA Complaint Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements; such as Maintain processes to ensure high quality products and compliance with current standards; documentation reviews; support quality audits; and data analysis.

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 Are We Looking For
  • A Minimum of a Bachelor’s Degree in engineering, natural sciences or another related field is required
  • Work experience in quality in a pharma/medical device or other regulated industry is a major plus
  • Investigative & analytical critical thinking skills
  • Strong decision-making skills and able to make sound business decisions with sometimes limited information
  • Continuous interaction with global groups and the ability to collaborate with global customers is required
  • Strong written and verbal communication skills in English
This job based in Schaffhausen, Switzerland will initially be limited to approx. 16 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!
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Data limite: 05-05-2024

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