Stelis Biopharma Pvt. Ltd. ( Stelis) is a biopharmaceutical firm that provides a wide range of pharmaceutical products, including capsules and injections. Stelis operates as a fully vertically integrated company, encompassing various capabilities such as research and development, process development, scale-up, and end-to-end cGMP manufacturing. Situated in Bangalore, India, Stelis has established a commercial bio-manufacturing facility spanning 19,000 square meters for the production of drug substances and drug products.
Join Stelis Biopharma as an Associate/Senior Associate – Quality Control
Join Stelis Biopharma as an Associate/Senior Associate in Quality Control. Be part of a team dedicated to ensuring the highest standards of quality in biopharmaceuticals! We’re currently seeking talented individuals to join our QC department in Bengaluru, India. If you’re passionate about maintaining the integrity and efficacy of pharmaceutical products, we want you on our team!
Role: Associate/Senior Associate – Quality Control
Work Location: Doddaballapura, Bengaluru
Qualification: Master’s degree in Biochemistry/ Biotechnology/ Chemistry
Technical Skills: HPLC and GC method analysis, QC equipments Calibration (HPLC, GC), analytical method Validation, method transfer, Balance and pH meter Calibration and handling, Raw materials handling experience
Primary responsibilities:
- Preparation of quality system related, Instrument operation related SOPs, Specification, STPs, GTPs, raw data sheet, certificate of analysis etc.
- Preparation/review/execution of method transfer and method validation protocols and reports.
- Initiation of Change controls and implementation of procedure in routine analysis.
- Handling of Deviations and Out of specification and their CAPA management.
- Estimation of proteins through UV-Spectrophotometer.
- Analysis of DS, DP and stability study samples in quality control department as per procedures for different products using the HPLC Chromatography (Size Exclusion
- Chromatography, Ion Exchange Chromatography, Reverse phase Chromatography).
Maintain data integrity in all Activities at site and ensure appropriate and adequate traceability. - Instrument/Equipment qualification in Quality control.
- Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and safety policies.
- Handling and sampling of Raw materials.
- Coordination with Regulatory bodies, Internal and external customers, Vendors and service providers and internal and external trainings.
Apply now:
Email your resume to: J.DhanaVignesh@stelis.com | Email subject: Quality control – Stelis
Or apply here
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