Senior Specialist Quality Assurance R&D Analytics

Við leitum að drífandi einstaklingi til að ganga til liðs við R&D Quality teymi Alvotech.

Þessi staða felur í sér að veita stuðning við gæðamál og samræmi í tengslum við þróun og staðfestingu greiningaraðferða. Greiningaraðferðirnar sem eru þróaðar og staðfestar eru notaðar við reglubundnar prófanir og stöðugleikaprófanir á líftæknilyfjum og styðja við skráningarferli hjá eftirlitsaðilum. Við leitum að einstaklingi með góðan skilning á meginreglum sannprófunar aðferða, gæðastjórnunarkerfi (QMS) og góðum framleiðsluháttum (cGMP). Umsækjandi þarf einnig að hafa innsýn í hvernig beita má gæðakerfum sem eru í samræmi við þróunarstig innan R&D.

Helstu Verkefni Og áByrgð:

• Leiðir þverfagleg verkefni og sinnir fjölbreyttum verkefnum.
• Vinnur náið með R&D Analytics við gæðamál og leiðbeinir við framkvæmd gæðatengdra ferla.
• Framkvæmir QA yfirferð á ýmsum skjölum sem tengjast gæðum og eru unnin af R&D Analytics.
• Fer yfir og samþykkir breytingastýringar, leiðréttingar (CAPA), frávik og villur í staðfestingu aðferða.
• Fer yfir og samþykkir verklagsreglur (SOP), Method Software Specifications (MSS) og önnur stuðningsgögn til að tryggja að aðferðir séu tilbúnar til yfirfærslu í QC rannsóknarstofu.
• Tekur þátt í innri og ytri úttektum og samskiptum við eftirlitsaðila.
• Tekur þátt í hönnun á gæðastjórnunarkerfi sem hæfir þróunarstigi verkefna.

Menntunar- Og HæFniskröFur:

• BS/MS gráða í efnafræði, lífefnafræði, líftækni eða sambærilegri grein.
• Þekking á eðlisefnafræðilegum og lífefnafræðilegum greiningaraðferðum og ferlum innan gæðakerfa eins og CAPA, breytingastýringum, rannsóknarferlum og skjölun.
• Að lágmarki 5 ára reynsla í gæðaeftirliti eða gæðastjórnun innan líftæknilyfjaiðnaðarins er æskileg.
• Góð þekking á regluverki GxP og reynsla af stuðningi við úttektir, þar á meðal FDA og EMA.
• Reynsla af notkun rafræns skjölunarkerfis (eDMS) er kostur.

[English]

We are looking for a motivated individual to join the R&D Quality team in Alvotech. This role provides Quality and Compliance related support for Analytical method development and validation activities across Alvotech sites. The test methods developed and validated are used for routine and stability testing of Biosimilars and support regulatory submissions. Potential candidate for this role understands the principles of method validations, Quality Management System (QMS) and cGMP.

Scope And Responsibility:

• Routinely leads important cross functional projects and performs variety of tasks of variable complexity.
• Collaborate with R&D Analytics 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 analytics (e.g., Method lifecycle documents, scientific reports, and data sets).
• Review and approve Change controls, CAPA, Deviations, and errors in method validations.
• Review and approve Standard Operating Procedures (SOP), Method Software Specifications (MSS), and other supporting documents to assure test methods are in a state of transfer to QC laboratory.
• 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).

Job Requirements:

• Bachelor‘s/Master‘s degree in chemistry, biochemistry, biotechnology or equivalent.
• Knowledge of Physiochemical/Bioanalytical methods, and Quality system processes such as CAPA, Change controls, Investigations, and document management, etc.
• Minimum 5 years’ experience in Analytical 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.