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.

Vinnustaðurinn

QC Microbiology Manager

Alvotech is currently seeking a highly skilled and experienced Quality Control Manager for Microbiology Testing Operations to join our Microbiology team in Reykjavik. This role involves a high degree of responsibility, leading and optimizing our microbiology laboratory operations, good leadership skills and demands a comprehensive understanding of importance of efficient operations, maintaining compliance to regulations, thorough understanding of various techniques and microbial processes. If you're seeking an exciting role where you can utilize your expertise and make a significant impact, this opportunity is for you.

Helstu verkefni og ábyrgð

Management and oversight of the Microbiology testing department within Quality Control with responsibility of ensuring all testing activities related to microbial analysis are conducted accurately, efficiently, and in compliance with regulatory standards, ensuring product quality and safety
Overseeing all scheduling and coordination of all Microbial testing ensuring timely reporting of data, supporting manufacturing operations on multiple levels
Play a role in the day-to-day management of the Quality Control department and help to establish and maintain departmental metrics
Lead CAPAs, Change controls, and OOS/OOT/OOE investigations
Lead deviation investigations, and support team in resolving them
Support laboratory investigation
Review and approve generated technical documentation within the document management system
Maintain regulatory readiness, participate actively in regulatory preparation and inspections
Represent Quality Control within project team meetings as appropriate and providing SME (subject matter expert) support in relation to dossier activities.
Provide oversight and technical guidance, ensuring an optimal level of scientific ability and training within the department
Identify required document changes and empower staff to implement changes promptly
Collaborate with fellow Managers and Team Leaders on departmental initiatives as well as cross functional activities.
Manage shift schedules and working hours.

Menntunar- og hæfniskröfur

M.Sc in Microbiology or relevant scientific discipline
5+ years of experience in Pharmaceutical or Biopharmaceutical industry and a direct experience in the field of Microbiology.
Strong understanding of microbial processes and regulatory compliance
Demonstrated scientific and leadership skills. Experience leading teams of scientists with varying levels of experience is required, with the ability of mentoring and fostering an accountable team culture.
Good conceptual, problem solving, and organizational skills – must be detail-oriented, well organized, and able to work independently and in teams

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.

Auglýsing birt22. október 2024

Umsóknarfrestur5. nóvember 2024

Tungumálahæfni

Enska

Nauðsyn

Mjög góð

Staðsetning

Sæmundargata 15-19 15R, 101 Reykjavík

Starfstegund

Starfsgreinar

Starfsmerkingar

Fleiri störf (8)