gmp compliance specialist // johnson & johnson in Zuchwil

posted
contact
Stefanie Aerni, Randstad Inhouse Services Actelion
job type
temporary
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job details

posted
location
zuchwil, solothurn
sector
administration
job type
temporary
reference number
138873-202
contact
stefanie aerni, randstad inhouse services actelion
phone
058 231 36 15

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. 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.

DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.

Main Responsibilities

As part of the Regulatory Compliance team of DePuySynthes, this role provides Quality System Compliance support to the assigned site(s). This includes the procedures and records required for the development, deployment and maintenance of quality system processes in order to assure the ongoing compliance with ISO13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.

  • Prepare and maintain regulatory inspection readiness plans for assigned sites
  • Execute internal audit as per approved schedule for other DePuy Synthes sites (worldwide scope, products and technologies)
  • Lead all assigned quality actions, and ensure all internal and external audit observations are investigated, have causes identified, action plans completed, and appropriate effectiveness monitoring
  • Ensure proper internal audit reporting, response review and approvals, communication of issues, and use of tracking and trending tools to monitor site compliance performance
  • Coach and develop users on Audit system as well as regulation requirements
  • Drive Compliance improvements, which result from internal audits, Quality Board Issues and other system indicators
  • Provide Front Room/ Back Room support during external audits
  • Guide Quality System Auditors and support staff as required to ensure appropriate control systems are in place and continually improved to meet changing regulatory, corporate and industry standards

qualification

Who we are looking for

  • University degree in Science, Engineering, Quality or other technical field
  • Equivalent degree and/or adequate associated work experience is acceptable
  • Work experience in a regulated industry
  • Work experience in a quality and/or compliance function is a major plus
  • Qualification as Auditor
  • Knowledge of Quality Systems (21 CFR 820/ISO 13485) within a regulated environment
  • Very good communication in English, French is advantageous

This role based in Zuchwil, Switzerland will initially be limited to approx. 12 months with the possibility to extend. 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!