Jul 21, 2022

Job Description

1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.

This role utilizes Microbiological laboratory skills to test and measure product or materials while ensuring
that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical
Methods, and current Compendial.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• Microbiological evaluation of starting materials finished dosage forms, Stability samples, Water
analysis and Environmental Monitoring.
• Handling of Microbial Limit Test, Sterility test, LAL test (Bacterial Endotoxins test), Water
microbiological analysis /TOC, Growth promotion test, Microbial Assay, Preservative
Effectiveness testing and Environmental monitoring.
• Preparation of annual / quarterly / monthly testing /qualification / PM schedules to ensure
adherence to the respective SOP requirements.
• Perform media preparation activity along with completion logbooks and relevant records.
• Calibrate instruments used for analysis as per SOP and maintain its record. Perform
validation activities viz., cleaning validation, process validation as and when required.
• Prepare validation / verification protocol / report of testing methods and execute protocols, as
per requirement.
• GMP & abiding and ensuring compliance to the Health, Safety & Environment policy.
• Ensure compliance with Pharmacopoeial / Group / Local / International health authority
• Completion of all trainings assigned to role.
• Collaboration with CMO/CRO/ST/NTO
• Handling of OOS, OOE and investigations
• Preparation, review and approval of technical documents and reports.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• PhD with 2-3 years of experience on mass spectrometry Master of Science with 5-7 year of relevant experience Fluency in English language
• Minimum 5 years in Quality function preferably in a USFDA/ EU-GMP regulatory organization.
• Sound technical & scientific knowledge of pharmaceutical/ aseptic techniques/QC/ equivalent
Working experience in Laboratory environment in the Pharmaceutical industry.
• Microbial Testing & Sampling.
• Laboratory Equipment Handling.
• Handling of Microbiology Lab instruments and equipment

Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Product Dev SZ
Hyderabad, AP
Research & Development
Full Time
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Scientist (Microbiology)

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