Reyndur sérfræðingur í gæðaeftirliti / Principal/Senior Specialist Quality Assurance R&D

Alvotech leitar að öflugum einstaklingi í teymi rannsókna og þróunar (R&D Quality) sem sinnir gæðamálum og reglufylgni tengdum þróun og sannprófun ferla og afurða á starfsstöðvum Alvotech. Þeir ferlar og afurðir sem þróaðir eru innan R&D eru yfirfærðir til innri og ytri framleiðslustöðva fyrir framleiðslu á líftæknilyfjum (biosimilars).

Viðkomandi þarf að búa yfir traustri þekkingu á meginreglum ferla- og afurðaþróunar, gæðastjórnunarkerfum (QMS) og framleiðsluháttum (cGMP). Einnig er mikilvægt að skilja hvernig á að innleiða stigbundin gæðakerfi sem henta starfsemi rannsókna og þróunar.

Helstu Verkefni Og áByrgð:

• Leiðir þverfagleg verkefni og sinnir fjölbreyttum verkefnum.
• Vinnur náið með R&D við dagleg verkefni tengd reglufylgni og veitir leiðsögn við framkvæmd gæðaferla.
• Framkvæmir gæðaskoðun (QA review) á ýmsum gæðaskjölum (t.d. ferlislýsingar, tæknileg samantektarskjöl, PAR o.fl.).
• Fer yfir og samþykkir breytingastýringar (Change Controls), leiðréttingaraðgerðir (CAPA), frávik og misræmi.
• Fer yfir og samþykkir vinnulýsingar (SOP), skjöl um breytingar á gögnum og önnur fylgiskjöl til að tryggja að ferlar séu undir stjórn og tilbúnir til yfirfærslu í framleiðslu.
• Tekur þátt eftir þörfum í innri úttektum og skoðunum heilbrigðisyfirvalda, sem og öðrum samskiptum við reglugerðaraðila.
• Leggur sitt af mörkum eftir þörfum við hönnun á stigbundnu gæðastjórnunarkerfi (QMS) sem hæfir þróunarstigum R&D.

Menntunar- Og HæFniskröFur:

• Menntun: B.Sc./M.Sc. gráða í efnafræði, lífefnafræði, líftækni eða sambærilegum greinum.
• Góð þekking á þróun ferla og afurða fyrir virka lyfjaefnið og lyfjaafurðina, auk gæðakerfa eins og CAPA (leiðréttingaraðgerðir), breytingastýringar, rannsóknir á frávikum og skjölunarkerfi.
• Þekking á framleiðsluferlum einstofna mótefna (monoclonal antibodies) er kostur.
• Að lágmarki 5 ára reynsla af gæðastjórnun innan líftæknilyfjaiðnaðarins er æskileg.
• Djúpstæður skilningur á GxP kröfum og reynsla af þátttöku í reglugerðarskoðunum, þar á meðal frá FDA og EMA.
• Reynsla af notkun rafræns skjölunarkerfis (eDMS) er kostur.

[English]

This role is within R&D Quality that provides Quality and Compliance related support for process and product development and validation activities across Alvotech sites. The process and products developed in R&D are transferred to internal and external manufacturing sites for commercial manufacturing of Biosimilar products. The candidate will have a solid understanding of process and product development principles, Quality Management Systems (QMS), and current Good Manufacturing Practices (cGMP). They should also understand the application of phase appropriate quality management systems in R&D department.

Key Responsibilities:

• Routinely leads important cross functional projects and performs variety of tasks of variable complexity.
• Collaborate with R&D partner in daily compliance activities and coach in executing quality related procedures.
• Execute QA review of various quality related documents generated by functional units in R&D (e.g., Process characterization, Technical summary reports,  PAR etc.).
• Review and approve Change controls, CAPA, Deviations, and discrepancies.
• Review and approve Standard Operating Procedures (SOP), Document change controls, and other supporting documents to assure processes are in a state of control and transferrable to commercial manufacturing.
• Contribute as required in internal and health authority inspections and any other interactions with regulatory agencies.
• Contribute as required in design of phase appropriate Quality Management System (QMS).

Qualifications:

• Education: Bachelor‘s/Master‘s degree in chemistry, biochemistry, biotechnology or equivalent.
• Knowledge of process and product development of drug substance and drug product, and Quality system processes such as CAPA, Change controls, Investigations, and document management, etc.
• Knowledge in monoclonal antibodies manufacturing processes would be an advantage.
• Minimum 5 years’ experience in quality assurance/quality management function in biopharmaceutical industry is desired.
• Thorough understanding of regulatory GxP requirements and experience in supporting regulatory audits including FDA, and EMA.
• Experience in using eDMS is an advantage.

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.