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.

About

Quality Specialist - Management Controls

Are you passionate about ensuring the highest standards of quality and compliance? We are seeking a dedicated and detail-oriented Quality specialist for Management Controls to join our Compliance team. In this role, you will play a crucial part in managing quality management review, setting and following up on metrics for key performance indicators, and ensuring our site is always inspection ready. You will be involved in the preparation and participation of incoming audits and inspections, as well as responding to findings and participating in CAPA resolution. Your expertise will help us maintain compliance with regulations and drive continuous improvement across all departments. If you are an experienced Quality professional with a keen eye for detail and a commitment to excellence, we would love to hear from you!

Helstu verkefni og ábyrgð

Participating and managing the quality management review.
Participating in setting appropriate metrics and follow up on metrics set by the facility.
Ensuring inspection readiness of the site and ensuring that the inspection readiness program is effective.
Participate in the management, preparation and execution of incoming audits and inspections.
Participate in responses of inspections and audit findings.
Participate in CAPA resolution and approval of inspection and audit findings.
Follow up on that CAPA commitments from incoming audits and inspections are closed on time.
Strive to work with all cross functional departments on improvements to ensure compliance to regulations.

Menntunar- og hæfniskröfur

University degree in pharmacy, biotechnology, biochemistry, chemistry, biology, or related fields.
5+ years of experience in pharmaceutical industry.
Experience in working with quality systems and GMP environment of pharmaceutical manufacturing.
Good knowledge of Quality Systems and risk-based decision making.
Excellent project management skills.
Attention to detail and precise work habits.
Good communication skills.

Fríðindi í starfi

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.

Advertisement published20. March 2025

Application deadline9. April 2025

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