Senior QA Specialist

Job Description Summary

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!

 

Job Description

Your responsibilities:

• Preparing, verification, completing the necessary documentation supporting the registration processes of medicinal products
• Active participation in the processes of: deviations, risk analyses, change control, implementation of corrective and remedial actions;
• Evaluation changes significant from the registration point of view,
• Providing support in matters related to registration processes, preparation of declarations and statements for registration purposes.
• Development and supervision of quality agreements related to the production and import of medicinal products
• Development and participation in the preparation of the Annual Product Quality Review Initiation of activities related to the improvement of the functioning of the Quality System, both in the area of ​​quality assurance and in other areas.
• Participation in the preparations for inspections and audits; substantive support during inspections/audits.
• Preparing Quality System documents

Our requirements:

• University degree in chemistry, pharmacy, biology or related science
• At least 3 years experience in the pharmaceutical industry
• Very good knowledge of pharmaceutical law and GMP requirements
• Highly developed communication and organizational skills
• English- upper-intermediate
• Awareness of influencing others, building commitment

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!

Join us!

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool

#Sandoz

 

Skills Desired

Action-Oriented, Compliance Requirements, Continued Learning, Dealing With Ambiguity, Functional Skills, Gmp Procedures, Gxp, Industry Standards, Process Optimization, Qa (Quality Assurance), Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence