Principal/ Senior Specialist Pharmaceutical Sciences Quality

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.

We offer a fun and challenging job in an international environment with diverse opportunities for professional development. If this exciting opportunity interests you, we invite you to explore further details on our website.

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