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

Specialist – Engineering & CSV Compliance

Join our newly formed team within the Quality division at Alvotech, a leading biosimilar pharmaceutical company. As a Specialist in Engineering & CSV Compliance, you will collaborate with various departments to oversee qualification and validation activities for facilities, utilities, and equipment. You will serve as a Quality representative and subject matter expert, ensuring compliance with EU and US legislation for parenteral manufacturing. Your role will involve supporting QA oversight, reviewing and approving qualification documents, change controls, deviations, and CAPAs, and contributing to investigations and corrective actions. We seek a candidate with a bachelor's degree in a relevant area, at least 3 years of experience in the pharmaceutical or medical device industry, and a strong understanding of GAMP 5 guidelines.

Helstu verkefni og ábyrgð

Accountable for completing own tasks or assignments
Receives assignments from a leader or senior colleague
Performs mostly routine tasks within procedures and processes but occasionally non-routine tasks
Challenges and decisions are discussed, made and solved in cooperation with supervisor or other employees
Can make adjustments or changes to procedures, processes and (occasionally) projects.
Advanced knowledge within field of expertise such as methods, techniques and equipment as well as relevant procedural/process knowledge (SME)
Main scope is local or internal that can require immediate or urgent expert attention

Menntunar- og hæfniskröfur

A bachelor’s degree within relevant area, or other relevant business experience
Ongoing relevant courses and training activities.
Minimum 3 years of experience within the pharmaceutical or medical device industry
Minimum 2 years Quality Assurance experience
Experience working with regulatory requirements in GxP required
Good understanding of GAMP 5 guide required.
Knowledge of and experience with validation and qualification specifically within facility, utility, and equipment

Advertisement published8. May 2025

Application deadline5. June 2025

Language skills