Specialist QA Release

☞ Johnson & Johnson

View: 121

Update day: 25-04-2024

Location: Schaffhausen Schaffhausen SH

Category: Quality Assurance / Quality Control

Industry: Hospitals Health Care

Job type: Full-time

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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. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable CredoCilag AG in Schaffhausen, Switzerland is part of the Janssen Supply Chain organization, within Johnson & Johnson.We manufacture high quality pharmaceutical products and active pharmaceutical ingredients (APIs). Today Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all the major global markets. The Schaffhausen facility is a Johnson & Johnson strategic launch and growth site for parenteral products, and we have an impressive pipeline of new and innovative products!The QA Specialist performs quality activities in support of new and existing products. The position has a great deal of interaction with many internal departments, including Planning, Manufacturing, Quality Control, and local/global Stakeholders. The QA 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 analysisSpecialist QA Release(Fixed-Term Contract)Specific Responsibilities
  • Execute proper review of batch record documentation for Incoming Products, Bulk, Intermediate and Finished Good products for accuracy and completeness to ensure compliance with GMP regulations and all applicable internal procedures and policies.
  • Coordinate all activities related to batch record review and batch release with internal and external Quality, Planning and Quality Control teams within Janssen Supply Chain.
  • Execute batch release for Incoming Products, Bulk, Intermediate and Finished Good products as a delegate of local Qualified Person to ensure compliance with GMP regulations and all applicable internal procedures and policies.
  • Issue non-conformances records from batch review and release process and report them to quality organization and supply chain stakeholder.
  • Develop a common understanding of the entire batch release process for products in scope of the site.
  • Support internal, external, and third-party audits.
  • Support in projects and/or investigations, including process improvement activities
  • A Bachelor’s Degree in engineering, physical, biological, natural sciences or other related field is required.
  • A minimum of 2 year of experience in quality in a pharma/medical device or other regulated industry is required. (Previous experience with batch record or batch release handling is preferred)
  • Investigative & analytical critical thinking skills.
  • Strong decision-making skills – able to make sound business decisions with sometimes limited information.
  • Effectively manages work & time to produce desired outcomes (time management).
  • Continuous interaction with local groups and the ability to collaborate with global customers is required.
  • German proficiency is a must.
  • Good written and verbal communication skills in English
  • Managing multiple priorities, maintaining confidentiality, and operating with poise and integrity in a sophisticated, high-profile, matrixed and constantly evolving environment is required.
You are a proactive person with a quick grasp and enjoy working in a team. You can expect a varied task in an interesting environment with attractive conditions and an excellent infrastructure.Have we piqued your interest? We look forward to receiving your application with cover letter, CV and references on our career portal.Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.Primary LocationEurope/Middle East/Africa-Switzerland-Schaffhausen-SchaffhausenOrganizationCilag AG (8562)Job FunctionQuality AssuranceJob QualificationsRequired skills and experience
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Deadline: 09-06-2024

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