Alvotech leitar að metnaðarfullum sérfræðingi til að ganga til liðs við teymið okkar. Í þessu hlutverki munt þú styðja við starfsemi í framleiðslu líftæknilyfja, tryggja að farið sé eftir cGMP‑stöðlum og leggja þitt af mörkum til stöðugra umbóta í framleiðsluumhverfinu. Við leitum að lausnamiðuðum einstaklingi sem nýtur þess að starfa í fjölbreyttu og krefjandi vinnuumhverfi og hefur áhuga á að viðhalda hámarks gæðum og reglufylgni.
[English]
Alvotech is seeking a dedicated and detail‑oriented Manufacturing Compliance Specialist to join our team. In this role, you will support key quality operations within biomanufacturing, ensure adherence to cGMP standards, and contribute to continuous improvement across our production environment. We are looking for someone who thrives in a dynamic setting, enjoys problem‑solving, and is committed to maintaining the highest standards of quality and compliance.
Key Responsibilities
Initiating deviation and performing investigations for deviation reported in Manufacturing.
Assisting in creating and reviewing documents such as Standard Operating.
Owning Deviations Handling (Non-process, system/facility, and utility related), CAPAs, change controls and Change actions.
Trending DEVs in MFG and identifying the Areas for improvement.
Develop and maintain metrics to track batch records and deviation turnaround time and assess areas of improvement.
Review facility-related risk assessment, EMI deviations and EM trend reports.
Providing compliance oversight during biomanufacturing runs including Oversee cGMP activities within DPM production areas (Grade A, B, C and CNC).
Troubleshooting and review and approval of quality documents such as planned changes.
Tracking and support on-time closure of Quality Records and maintaining compliance against KPIs for the below Quality Records.
Effectiveness checks applied for Quality Records.
Performing monthly EHS inspection on the production floor.
Supporting the review of process logbooks and other GMP records in Manufacturing.
Conducting routine facility walkthrough and ensuring that the manufacturing area is maintained in a state of compliance and inspection readiness.
Contribute as required to regular audits, and interactions with regulatory agencies.
Qualifications
Degree/Diploma in related discipline or sufficient relevant experience.
Knowledge in DP operations is additional benefit to this role.
Knowledge of regulatory guidelines for biomanufacturing (FDA, ICH, PIC/s) and implementation.
Minimum 3 years in compliance role for biomanufacturing, desired.
Experience in supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
Expertise working with up-to-date cGMP compliance and associated documentation.
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.
Skills Required
- Degree or diploma in a related discipline or equivalent relevant experience
- Minimum ~3 years' experience in a biomanufacturing compliance role
- Experience managing deviation investigations, CAPAs, change controls, and quality records
- Expertise with current cGMP compliance and associated documentation
- Knowledge of regulatory guidelines and implementation (FDA, ICH, PIC/s) and working with international agencies
- Experience supporting Pre-Approval Inspections (PAI) and interactions with FDA and EMA
- Knowledge of downstream processing (DP) operations
What We Do
Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.
