Principal/ Senior Specialist Pharmaceutical Sciences Quality – R&D Quality Generalist

Alvotech is looking for a new member to join Pharmaceutical Sciences Quality. The department provides Quality and Compliance related support for multiple R&D activities across Alvotech sites. Potential candidate for this role understands the need for, and application of phase appropriate control across the development lifecycle within R&D, principles of method validations, Quality Management System (QMS) and cGMP.

Pharmaceutical Sciences (PharmSci) Quality (PSQ) is a function within R&D focused with quality oversight on development and validation activities at Alvotech across the development lifecycle.

Key Responsibilities:

• Routinely leads cross functional projects and performs variety of tasks of variable complexity.
• Collaborate with R&D partners in daily compliance activities and coach in executing quality related procedures.
• Execute QA review of various quality related documents generated by functional units in R&D analytics (e.g., method lifecycle documents, scientific reports, and data sets).
• Review and approve Change controls, CAPA, Deviations, and errors in method validations.
• Review and approve Procedures, Method Software Specifications (MSS), and other supporting documents.
• Contribute as required in internal and health authority inspections and any other interactions with regulatory agencies.
• Contribute as required in design of phase appropriate Quality Management System (QMS).

Qualifications:

• Bachelor‘s/Master‘s degree in chemistry, biochemistry, biotechnology or equivalent.
• Knowledge of Physiochemical/Bioanalytical methods, and Quality system processes such as CAPA, Change controls, Investigations, and document management, etc.
• Minimum 5 years’ experience in Analytical quality assurance/quality management function in biopharmaceutical industry is desired.
• Thorough understanding of regulatory GxP requirements and experience in supporting regulatory audits including FDA, and EMA.
• Experience in using eDMS is an advantage.

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.