Overview of role:
Við leitum að metnaðarfullum og reyndum gæðasérfræðingi til að ganga til liðs við gæðaeftirlitsteymið okkar. Starfið felur í sér sjálfstæð vinnubrögð, reglulega verkefnastjórn og umsjón með litlum til meðalstórum teymum. Verkefnin eru bæði reglubundin og fjölbreytt, og viðkomandi hefur svigrúm til að endurskoða og þróa ferla, verklag og verkefni.
(English)
We are seeking a highly motivated and experienced QA Specialist to join our Quality Assurance team. The successful candidate will be Independent in assignments. Routinely leads projects and/or supervises small or medium-sized teams of technicians or admin. Performs both routine tasks within procedures and processes and non-routine tasks. Take part in large projects. Challenges and decisions are discussed, made and solved in cooperation with supervisor/other employees. Can make adjustments/changes to procedures, processes, and projects.
Key Responsibilities:
- Vera QA tengiliður fyrir DSM og DPM
- Veita almennan QA stuðning og sérfræðiþekkingu
- Styðja og samþykkja rannsóknir á frávikum, áhættumati og OOS, ásamt tengdum CAPAs
- Yfirfara og samþykkja breytingaskrár (Change Control)
- Taka þátt í lausn CAPA sem tengjast athugasemdum úr eftirliti
- Yfirfara og samþykkja lotuskjöl og tengd skjöl frá DSM og DPM
- Yfirfara og samþykkja vörulýsingar og meginlotuskjöl
- Yfirfara og samþykkja skjöl og skýrslur sem tengjast ábyrgðarsviði
- Yfirfara og samþykkja SOP skjöl sem tengjast ábyrgðarsviði
- Styðja við undirbúning fyrir eftirlit samkvæmt skilgreindu hlutverki
- Þjálfa nýja meðlimi QA Operations og aðra starfsmenn eftir þörfum
- Taka þátt í stöðugri þróun gæðastjórnkerfisins
(English)
- Act as QA contact for DSM and DPM
- Provide general QA support and expertise for DSM and DPM
- Support and approve investigations of Deviations, Risk Assessments, and OOS including related CAPAs
- Review and approve Change Control records
- Help resolve CAPAs from inspection findings
- Review and approve batch records and related documents from DSM and DPM
- Review and approve product specifications and master batch records
- Review and approve documents and reports related to your area
- Review and approve SOPs related to your area
- Support inspection preparation as defined in your role
- Train new QA Operations team members and other staff as needed
- Contribute to continuous improvement of the Quality Management System
Qualifications:
- BSc gráða í lífvísindum, lyfjafræði eða skyldu sviði (eða sambærileg reynsla)
- Fyrri reynsla af QA starfi í lyfjaiðnaði eða líftæknifyrirtæki er æskileg
- Góð þekking á GMP, EMA, FDA reglum og stöðlum iðnaðarins er æskileg
- Sterk samskipta- og samvinnuhæfni
- Geta til að vinna sjálfstætt og forgangsraða verkefnum í hraðvirku umhverfi
- Góð færni í ensku, bæði í rituðu og töluðu máli
(English)
- Bachelor’s degree in Life Sciences, Pharmacy, or related field (or equivalent experience)
- Previous QA experience in pharma or biotech is preferred
- Good understanding of GMP, EMA, FDA regulations, and industry standards is preferred
- Strong communication and teamwork skills
- Ability to work independently and prioritize in a fast-paced environment
- Proficient in written and spoken English
About the Department
Gæðaeftirlitsdeildin (Quality Operations) samanstendur af reyndum og metnaðarfullu starfsfólki sem leggja áherslu á gæði í allri framleiðslu og prófun vara hjá Alvotech. Hlutverk deildarinnar er að yfirfara og samþykkja öll skjöl sem tengjast framleiðslu og prófun lyfja, styðja við háþróaða framleiðsluferla og sjá um afgreiðslu lyfjaefnis og lyfjavöru.
(English)
Quality Operations department is comprised of experienced and dedicated quality-minded employees responsible for quality oversight of all manufacturing and product testing at Alvotech. The emphasis of the group is to review and approve all manufacturing and product testing documentation, to support the state-of-the-art manufacturing processes, and finally perform product disposition of the drug substance and drug product.
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.
