Job Description Summary
-The role is responsible for coordination and management of analytical equipment related activities as well as to provide scientific analytical Support. This includes the evaluation, development and validation of methods required for raw materials and finished products. -Performs qualitative and quantitative analyses of organic and inorganic compounds to determine the identity, purity and homogeneity of drug substances and products related to each project. -Organizes and interprets all data obtained using a wide variety of instrumental technologies
Job Description
Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable biosimilar and generic medicines. As we move forward on this new and ambitious path, unique opportunities will arise, both professionally and personally. Join us—the future is in our hands!
Major accountabilities:
- Statistical analysis -Support transfer projects -Product and process validation support -Validation and qualification analytics -Method transfer -Implementation of new techniques/technologies -Method optimization -Equipment qualification -Equipment calibration -Equipment breakdown management -Implementation of new technologies -Preparation of equipment qualification plan -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
- No delay in registration and APR/PQR due to faulty stability study design -No critical delays in study start – approved protocol available on time, prompt storage of stability samples -Stability Study reports and evaluation documents available on time; proper support for method transfer activities and other transfer projects -Timely evaluation and communication of transport temperature excursions -Additional KPIs as defined within the management team -Samples and associated documents are delivered to the laboratories on time.
Minimum Requirements:
Work Experience:
- Sound technical & scientific knowledge of pharmaceutical/ chemical.
- analytics/QC/ equivalent.
Skills:
- Communication Skills.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Gxp.
- Industry Standards.
- Laboratory Equipment.
- Laboratory Excellence.
- Quality Control (QC) Testing.
- Quality Control Sampling.
- Self-Awareness.
- Technological Expertise.
- Total Quality Management.
Languages:
- English.
Why Sandoz?
Generic and biosimilar medicines are the backbone of the global pharmaceutical industry. Sandoz, a leader in this sector, provided more than 900 million treatments to patients in over 100 countries in 2024. And while we are proud of this achievement, we aspire to do even more! Through investments in new development capabilities, production facilities, acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients access high-quality, affordable medicines in a sustainable way.
Commitment To Diversity And Inclusion
We are committed to creating an exceptional and inclusive work environment and diverse teams that represent the patients and communities we serve.
Skills Desired
Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management
📌 Digital QC Specialist
🏢 FCRS = MX016
📍 Insurgentes