Quality Assurance (Contractor)
Description
Is Kymanox the right fit for you?
You want to make a difference and have an impact…
You enjoy having an influence in your day-to-day work…
You are motivated by working alongside a team filled with
subject matter experts that will help you learn and grow…
You wake up every day and do what you do
… because patients deserve better.
If this sounds like you, you’ve come to the right place.
Kymanox is hiring a Quality Assurance Contractor remote role based Europe. We offer a motivating and dynamic work environment with a growing team with offices in Bern (CH), Lausanne (CH), and Munich (DE). Note that this position would be an hourly position and we are looking for someone who can provide assistance on an as needed basis.
Primary Responsibilities:
- Experience in the pharmaceutical/Biotech industry.
- Solid understanding of applicable regulation and guidelines e.g., 21 CFR 820, ISO 13485, and ISO 14971.
- Experience in QMS requirements; implementation and giving guidance on creating SOPs/QMS.
- Certified auditor, experience in the preparation, support and leading regulatory inspections and internal/external audits and represent QA in inspections and audits an SME.
- Experience as quality assurance responsible, including review and approval of changes, deviations, follow-up on CAPAs etc. to ensure compliance with internal and regulatory requirements.
Minimum Qualifications:
- Bachelor’s or master’s degree in a scientific, engineering, or other technical discipline
- 5+ years of experience in the combination products, medical device and/or pharmaceutical/drug sectors
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About Kymanox:
Kymanox (‘ki-mah-noks’), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pride… because patients deserve better.
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.