Alvotech hf
Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð, þar sem yfir 1000 starfsmenn af um 64 þjóðernum vinna að því að móta framtíðina á sviði líftæknilyfja og auka aðgengi sjúklinga um allan heim að hágæða lyfjum. Margir af færustu vísindamönnum landsins starfa hjá fyrirtækinu.
Við leyfum fjölbreytileika, forvitni og frumkvæði starfsfólks að njóta sín. Við bjóðum aðlaðandi starfsumhverfi í stöðugri mótun og ögrandi verkefni. Alvotech tryggir að jafnrétti kynjanna til launa og frama nái til allra starfsmanna, hérlendis jafnt sem erlendis. Við viljum laða að okkur færasta fólkið á hverju sviði, án tillits til uppruna eða kyns. Með þessum hætti getum við best þjónað hagsmunum sjúklinga og samstarfsaðilum okkar.
Vertu með okkur í að bæta lífsgæði fólks og auka aðgengi að hagkvæmum líftæknilyfjum.
Qualified Person
Alvotech is looking for a Qualified Person with a background in Sterile / Biological products to work with our dedicated QA Team and certify drug substances, drug products, and finished combination products.
Helstu verkefni og ábyrgð
- Performing the role of the Qualified Person through certification and oversight of Drug Substance, Drug Product, and Finished Combination Products.
- Provide QP expertise during the investigations of complaints, deviations, OOSs, and their related CAPAs.
- Provide QA review and approval of SOPs, reports, and other documentation
- Carry out routine risk/impact evaluations associated with product-based decisions or the quality system and participate in escalation situations.
- Communicating requirements and changes, acting as a content expert for audits and inspections using knowledge of associated systems.
- To keep up with the requirements of the Medicine Authorities across the EU and the rest of the world (where relevant).
Menntunar- og hæfniskröfur
- Experience within the pharmaceutical/biopharmaceutical industry for at least 5 years, preferably acting as a Qualified Person for at least 2 years.
- Eligible to act as a European Qualified Person certifying products in compliance with 2001/83/EC, 2003/94/EC, and Annex 16.
- Robust technical knowledge of EU GMP and GDP, regulations, and guidelines.
Fríðindi í starfi
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration, and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Company social events and milestone celebrations.
- Excellent in-house canteen and coffee house.
- Exercise and wellbeing support for full-time employees.
- On-site shower facility.
- Transportation grant towards eco-friendly modes of travel for full-time employees.
- Internet at home for full-time employees.
Advertisement published14. October 2024
Application deadline3. November 2024
Language skills
EnglishVery good
Location
Sæmundargata 15-19 15R, 101 Reykjavík
Type of work
Professions
Job Tags
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