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Quality

Lab Equipment Qualification Specialist

  • Titel Lab Equipment Qualification Specialist
  • Fungsi Quality
  • Sub Fungsi Quality Control
  • Golongan Lead Technician, Quality Control (S4)
  • Location Schaffhausen, Switzerland
  • Posted
  • ID Permintaan 2406195749W
Melamar Sekarang
Bagi

Deskripsi

Are you great at organizing knowledge and connecting dots? Do you enjoy having things in order and assuring that everything makes perfect logical sense? Are you the kind of person who is ready to find solutions to complex problems and stays level-headed when request pile up? Would you like to use these skills to improve lives of cancer patients at the frontier of medical research? If the answer to these questions is yes, we are looking for you!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

The Cilag AG is an international manufacturing company of the Johnson & Johnson Group's Janssen pharmaceutical division and manufactures pharmaceutical products and medical devices as well as active pharmaceutical ingredients (APIs) for global markets at its production site in Schaffhausen. With its innovative products, processes, and technologies, Cilag AG is one of the leading pharmaceutical companies in Switzerland and at the same time a strategic location for product launches.

Within the Quality Control (QC) department, we are looking for a dedicated personality as Lab Equipment Qualification Specialist (m/w/d, 80-100%)
in Schaffhausen (Switzerland) to commence immediately or by agreement.

What you will be doing:

As a specialist in laboratory equipment qualification, you will be joining a team which is passionate about introducing new and improving currently deployed laboratory equipment. You will be part of the Lab Services department of Site Quality Control and as such responsible for the lifecycle management of the laboratory equipment.

What impact will you also have:

As part of the Equipment Lifecycle Management team, it will be your task to qualify laboratory equipment. In addition, you will be supporting the investigation of instrument related deviations and the implementation of corresponding corrective and preventive actions. You will be the first point of contact  for all questions concerning the laboratory systems.
If you are also enthusiastic to ensure patient safety by implementing new laboratory equipment and improve lab equipment qualification, we would like to meet you.

In your day-to-day job you will:

  • Planning and coordinating qualification activities for laboratory equipment in compliance with current GMP and regulatory requirements
  • Preparation and execution of change control records related to equipment lifecycle management
  • Creation of detailed, comprehensive, and well-structured qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, IOPQ protocols and decommissioning documents)
  • Drafting of procedures (WIs, SOPs) related to equipment lifecycle management
  • Identification and documentation of relevant compendial requirements for analytical equipment
  • Operational support for the QC and R&D laboratories
  • Troubleshooting to diagnose and resolve problems
  • Supporting of investigations into deviations caused by non-conforming instruments and implement solutions (CAPA)
  • Liaise with vendors for problem resolution (e.g., technical support for manufacturer qualifications, maintenance & calibration, troubleshooting and investigations)

Kualifikasi

We would love to hear from you, if you have the following essential requirements:

You enjoy working in a team and have strong teamwork and communication skills. You approach challenges in a solution-oriented and systematic manner, can solve complex and multi-layered tasks and set the right priorities. In addition to your assertiveness, you are willing to take on responsibility and enjoy making a difference and advancing projects. In addition, you have the following qualifications:

  • MSc / BSc degree in Natural Sciences, Engineering, or alternatively comparable training with several years of professional experience
  • Experience with various analytical techniques, preferably in a regulated environment
  • Excellent communication skills
  • Experience in project management
  • Very good knowledge of Microsoft Office programs (Outlook, Word, Excel, PowerPoint)
  • Fluent in English and German

Nice to have:

  • Experience working with pharmacopeia
  • Hands on experience with instrument qualification and documentation (e.g., qualification of production plants, laboratory equipment)
  • Excellent analytical skills and problem-solving attitude
  • Experience with TrackWise, SAP and TruVault is an advantage

What type of mark will you make?

By joining Johnson&Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson&Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there’s no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson&Johnson means that “YOU belong”!

For more than 130 years, diversity, equity & inclusion 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 every one of our people feels that they belong and can reach their potential. No matter who they are.

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