Commissioning and Qualification Specialist

Overview of Role

The Commissioning and Qualification (C&Q) Specialist is responsible for leading and executing C&Q activities. The C&Q specialist makes sure all C&Q activities in manufacturing/lab areas are executed according to plans and GMP, and in good collaboration with all relevant parties.

Scope and responsibility

• Responsible for execution/management of commissioning and GMP qualification of equipment and systems at Alvotech.
• Responsible for ensuring that facilities, utilities, equipment (process and laboratory) are appropriately qualified in line with current EU and US legislation for parenteral biopharmaceuticals.
• Responsible for generating, executing, reviewing, and approving qualification documents per relevant company policies and SOPs.
• Generates, executes, reviews and approves key qualification documentation (e.g. System Impact Assessments, Validation Project Plans, User Requirements Specifications, Installation/Operational/Performance Qualification Protocols and Summary Reports) for new systems, released system, and system corrections and changes.
• Participate in change control, deviations and CAPA activities as required.
• Lead respectively to contribute to investigations of discrepancies arising during qualification activities and approval of appropriate corrective actions.
• Will work closely with Alvotech staff in the process of qualifying equipment/systems, including project managers, automation, QA, equipment/process owners and subject matter experts.
• Collaborate with various departments responsible for planning and executing specific qualification and validation activities, including Engineering for Facilities, Utilities and Equipment (process and laboratory).

Job requirement

• Technical education or higher (e.g. bachelor’s degree) in a related technical disciple.
• Knowledge of key GMP processes, e.g. documentation, qualification, change management, user requirement specifications, IQ/OQ/PQ execution.
• Knowledge of and experience with GMP documentation and handling of discrepancies.

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.