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Alvotech hf

Alvotech er fjölþjóðlegt hátæknifyrirtæki í fremstu röð. Meira en 1400 starfsfólk af um 70 þjóðernum sameinast um að móta framtíðina á sviði líftæknilyfja og tryggja sjúklingum um allan heim betra aðgengi að hágæða lyfjum. Meðal starfsfólks eru margir af færustu vísindamönnum landsins. 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 alls starfsfólks, 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.

Vinnustaðurinn

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.

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.

Auglýsing birt14. október 2024

Umsóknarfrestur3. nóvember 2024

Tungumálahæfni