QA Specialist Release

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

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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/

J&J MedTech is recruiting for a QA Specialist Release reporting to the Manager QA/QS and to be based in Uppsala (Sweden). The contract is a 1-year fixed term one for maternity cover.

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.

JOB POSITION SUMMARY

• Release final packed product to market (Including material needed)
• Review and approve documentation for disposition decisions regarding media, raw materials, incoming materials, components, pre-treated components, substance and products according to current qualification programs
• Develop and improve quality management processes and ensure that quality management processes within AMO Uppsala meet the requirements of the Division / Company
• Quality assurance deviations and CAPAs
• External inspections- Assist AMO's management during inspections of external parties
• Conduct trainings within GMP / QMS
• Quality assurance in projects

DUTIES & RESPONSIBILITIES

• Approve and verify deviations, actions and CAPA investigations
• Review and approve CAPA action plans, implementation and effectiveness checks
• Review and approve accounting and governing documents, (in e.g. validation, manufacturing, trials)
• Review and approve documentation such as Instructions belonging to affected processes AMO Uppsala
• Quality assurance of raw materials, packaging components and products
• Make dispositional decisions for media, raw materials, pre-treated components, incoming materials, components, substance and products according to current qualifications
• Participate as a QA representative in Change Control and Risk Management matters as well as in projects
• Continuous improvement of the quality management system
• Create/ update and approve SAP LIMS specifications/inspection plans

EXPERIENCE & EDUCATION

• Three-year academic university education with a pharmaceutical, scientific or technical orientation or equivalent
• Good knowledge of GMP/ISO regulations and regulations (EU GMP, 21 CFR Part 820, Part 210/211 and Part 11, ISO 13485, ISO 14001)
• Good oral and written proficiency in English and Swedish (local language)
• A minimum of 3 years of experience working in GMP controlled operations in the pharmaceutical industry and/or device manufacturing. Broad experience (e.g. quality system, production, lab, release, complaint handling)
• Good in taking initiatives