Quality Assurance Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

J&J MedTech is recruiting for a Quality Assurance Specialist reporting to the Manager QA/QS and to be based in Uppsala Sweden

Main responsibilities

• 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.
• Approve and verify deviations actions and CAPA investigations.
• Review and approve CAPA action plans implementation and effectiveness checks.
• Lead and run CC cases.
• 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.
• 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.
• Assess deviations validations qualifications and planned deviations.
• Create/ update and approve SAP LIMS specifications/inspection plans.

Experience and education

• Three-year academic university education with a pharmaceutical scientific or technical orientation or equivalent.
• Good knowledge of GMP/ISO regulationsand regulations (EU GMP 21 CFR Part 820 Part 210/211 and Part 11 ISO 13485 ISO 14001).
• Good oral and written proficiency in English.
• At least 5 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).

Knowledge

• Good GMP / ISO knowledge as well as knowledge of regulations and guidances (eg EU GMP 21 CFR Part 820 ICH Q1Part 210/211 och Part 11 ISO 13485 ISO 14001)
• Good IT skills
• Good knowledge of both Swedish and English in both speech and writing

Skills and abilities

• Ability to cooperate knows how to handle stress and stressful situations
• Goal-oriented Structured Responsible
• Independent Takes initiative Integrity
• Ability to plan and prioritize the departments goals and own work
• Ability for cross-functional collaboration between departments - and have a holistic view

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.