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**Job Function: **
Quality
**Job Sub Function: **
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Uppsala, Uppsala County, Sweden
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 Q1,Part 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 department's goals and own work
- Ability for cross-functional collaboration between departments - and have a holistic view
**Required Skills: **
Quality Assurance (QA)
Preferred Skills:
The anticipated base pay range for this position is:
kr413 000,00 - kr664 700,00
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 location’s 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.