QA Microbiology review specialist

Vertu hluti af gæðateyminu okkar og taktu þátt í að tryggja samræmi við GMP-kröfur með nákvæmri yfirferð, umsýslu og samþykkt örverufræðilegra gagna og framleiðslugagna frá gæðaeftirliti (QC). Starfið gegnir lykilhlutverki í að styðja við lotulosunarferli, viðhalda háum stöðlum í skjalastjórnun og tryggja að fyrirtækið sé ávallt tilbúið fyrir úttektir og eftirlit.

(English)

Join our Quality team and help ensure GMP compliance through accurate review, management, and approval of Microbiology and QC batch documentation. This role is critical in supporting batch release activities, maintaining documentation standards, and driving inspection readiness.

Scope & Key Responsibilities

• Review and approve Microbiology and QC batch documentation.

• Support batch release through review of records in MODA, LIMS, and related systems.

• Generate Environmental Monitoring (EM) batch summary reports.

• Ensure documentation complies with GMP procedures and quality requirements.

• Manage document control and archiving activities.

• Prepare, review, and approve SOPs and controlled documents in Veeva.

• Ensure Quality Events, CAPAs, and Change Controls are completed prior to batch documentation finalization.

• Track departmental KPIs and escalate documentation issues as needed.

• Support audit and regulatory inspection readiness.

Job Requirements

• BSc degree in Microbiology, Life Sciences, Biotechnology, Pharmacy, or a related field.

• Experience in a GMP-regulated pharmaceutical or biotechnology environment.

• Knowledge of microbiology, QC documentation, and quality systems.

• Familiarity with Veeva, MODA, LIMS, or similar systems is an advantage.

• Strong attention to detail and organizational skills.

• Excellent communication skills and ability to work cross-functionally.

• Fluent in English, both written and spoken.

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.