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J&J MedTech Sweden - Manager Quality Assurance/Quality Systems

  • Titel J&J MedTech Sweden - Manager Quality Assurance/Quality Systems
  • Fungsi Quality
  • Sub Fungsi Quality Assurance
  • Location Uppsala, Sweden
  • Posted
  • ID Permintaan 2406166645W
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Deskripsi

MedTech - Surgical Vision Uppsala (site)

With an eye for better vision

Johnson & Johnson Vision develops and manufactures optical products and solutions that make a difference to human vision worldwide. We offer market-leading technology for laser surgery, equipment for cataract surgery and intraocular lenses.

In Uppsala, we manufacture Healon, a market-leading product used to stabilize the eye in connection with eye surgery. Upon its launch in 1980, Healon paved the way for safe and quick eye surgery, whereby a patient’s cataracts can be replaced with new lenses in just a few minutes.

With over 130,000 employees, Johnson & Johnson is one of the world's largest and leading pharmaceutical and healthcare companies. Within J&J Vision – a part of the Johnson & Johnson MedTec business area - we are 8,400 employees, of which approximately 150 workers in our operations in Uppsala. Read more at www.jjvision.com

The roll of Manager Quality Assurance/Quality Systems involves understanding the JJSV Uppsala Quality Management System (QMS) and how it is related to specifics areas such as Quality Assurance, Quality Systems and Quality Compliance.

The position reports directly to the Quality Director at JJSV, Uppsala.

JOB POSITION SUMMARY

·       Overall cost center responsibility for cost centers within UQA

·       Quality assurance of product, raw materials/input materials, media and manufacturing processes

·       Process Owner for the Release Process, Amendment Process, Validation Process, Claims Process and Labeling Process

·       Operational planning, resource planning and KPIs are carried out within UQA Uppsala

·       Ensure that appropriate quality systems and controls are in place for monitoring and detecting deviations in critical processes, premises andÖvergripande kostnadsställeansvar för kostnadsställen inom UQA

·       Ensure that responsibilities and authority and working methods within UQA are regulated by written procedures that comply with applicable regulations

·       Operate in accordance with applicable regulations and standards, as well as GMP requirements for the markets where AMO Uppsala's products are marketed

DUTIES & RESPONSIBILITIES

·       Lead and develop the business so that AMO Uppsala AB and UQ's goals regarding quality & compliance, delivery reliability and cost efficiency are achieved

·       Resource and cost dimensioning QA/QS Quality Assurance/Quality System

·       Cost center responsibility for cost center 1213203450 according to current company policy for authorization rights

·       Member of the Quality Management Team

·       Delegated responsibilities on behalf of Q Director

·       Release. Ensure that the necessary testing and control

·       Validation. Ensure/maintain validated and qualified processes in manufacturing

·       Document management. Ensure that appropriate procedures and controls are implemented

·     Labelling management. Ensure that necessary procedures and controls are implemented to establish, maintain and modify printed materials used in AMO Uppsala's manufacturing

·       Administration of document management support systems (Agile) and training support systems (Compliance Wire)

Kualifikasi

·       Academic education with a microbiological, pharmaceutical, scientific or technical orientation or equivalent work experience in the pharmaceutical industry or other process industry (GMP or ISO13485)

·       Relevant leadership training for the position

·       Basic knowledge of financial accounting and budgeting

·       At least three - five years of work experience from quality work in the quality-certified laboratory or manufacturing industry

·       Experience in project management

·       Experience with previous work on Good GMP/ISO knowledge, as well as knowledge of regulations and guidances (e.g. CFR, pharmacopoeias)

·       Good IT skills

·       Good oral and written proficiency in both Swedish and English

LOCATION & TRAVEL REQUIREMENTS

NO specific travel requirements are indicated

The position is located at JSV Uppsala, Sweden

For more than 130 years, diversity, equity & inclusion (DEI) 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 in Nordics are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. 

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Application 

If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.  

If you have issues applying, please use Chrome Web Browser and reset your password. If that does not help you can get more guidance and contact us from this page: https://www.careers.jnj.com/contactus-faq

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