With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.
This role utilizes chemistry 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 Compendia at Oncology Kalwe Site.
Your key responsibilities:Your responsibilities include, but are not limited to:
- Sample storage and management. Analytical testing/documentation of drug product / finished product / complaints / stability / packaging material samples to GxP standards. Stability Testing/Sample storage and management. Analytical documentation of stability samples to GxP standards.
- Analysis of registration batches for tablet & capsule of semi-finished goods/Finished goods in accordance with Quality Control system and cGMP. Analysis of In-process samples and hold time study analysis of intermediate & final drug products.
- Analyst should have exposure for handling of Oncology product for drug substance & drug products. Analysis of raw material (Oncology-API/Excipients) as per current pharmacopoeia and in-house testing procedure and specification.. Analysis of water sample as per current pharmacopoeia. Analysis of cleaning verification/ validation samples.
- Having knowledge about analytical method transfer and perform analytical method transfer for drug substance & drug product. Experience on handling of Quality control instruments like HPLC, Gas chromatography software preferably for empower, dissolution tester, etc.
- Analysis of packaging material (Primary, Secondary & tertiary) as per current pharmacopoeia and current in-house testing procedure and specification. ave knowledge handling the Oncology product.
- To perform internal calibration of instruments. Timely submission of documents pertaining to day-to-day analysis to reviewer. Ensure safe working conditions as per guidelines issued by HSE department. Follow standard operating procedure of Quality control & analysis.
- Ensure Data Integrity, cGMP, GDP, ALCOA and ALCOA+ Principle at Workplace. Assisting supervisor Quality Control for efficient functioning of Quality Control Laboratory through QC analysis and good documentation as per quality control system. . To maintain all testing records, raw data & log books as per SOP.
- Maintain confidentiality and ensure safe custody and efficient handling of company document / material. Perform any other task that may be assigned for running of the company as per latest quality standard and Novartis Corporate Guidelines. Ensure efficient inter and intra department communications. Any other responsibility that may be assigned by supervisor/Manager from time to time. Follow Quality behaviors.
What you’ll bring to the role:
- M.Sc. in Chemicals /M. Pharm from reputed university.
- 3-7 years, Preferably in Oncology Quality control.
- Sound technical & scientific knowledge of pharmaceutical/ chemical analytics/QC/ equivalent Working experience in Laboratory environment in the Pharmaceutical industry.
- Laboratory Excellence & Laboratory equipment Quality Control (QC) Testing Quality Control Sampling Infrastructure Management Quality decision making.
- Knowledge of TQM and related industry GxP standards and processes.
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Group Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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