We are a fully integrated pure-play biologics Contract Development and Manufacturing Organization (CDMO), offering the complete spectrum of services, from cell line technology transfer to clinical and commercial manufacturing with capabilities to convert drug substance into stable formulations and fill and finish formats. We have proven technical expertise in microbial, mammalian, viral vectors, and various other technology platforms with world-class cGMP manufacturing facilities that offer high-quality services for your global programs.
Post : Associate / Senior Associate - Quality Control
Job Description
• 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.
Candidate Profile
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
Additional Information
Experience : 2-8 Years
Qualification : M.Sc
Location : Doddaballapura, Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Control
End Date : 30th May 2024
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