Provides strategic planning and implementation for the Quality System, including CGMP, GLP regulations, US 21 CFR Part 11 and guidelines to determine the impact to Quality Assurance Systems. Responsible for CAPA,OOT,OOS,Change Control & Deviations.
Oversee the implementation, maintenance, and continuous improvement of GLP systems and processes. Investigate and resolve any GLP-related deviations, non-conformances, or audit findings. Develop and maintain SOPs related to GLP compliance.
Regular Batch Analysis by using LCMS & GCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS Experience in E&L by GCMS
GTI & NDSRI by using LCMS. Review of Method Development & Method Validation Data Preparation of Protocols & Validation Reports Handling of Incidents, Deviations & Change Controls.
Handling of Laboratory Incidents, Change Control, Deviations OOS & OOT Handling of CAPA, Coordinate with technical team for timely closure of QMS documents. Writing SOP's. Support Internal & External Audit Finding Responses.
Responsible for Erection of Transformer, commissioning & testing Responsible for testing and Operation of DG sets. Troubleshooting and Preventive Maintenance & Testing of all types Pharma of Electrical and Mechanical Equipment’s.
HPLC Analysis Method Validations Method Developments. Calibrations. Forced Degradation Studies Required Candidate profile HPLC Analysis
Well versed with peptide characterization and analysis. Strong knowledge of amino acid sequencing, peptide finger printing and HMW impurity screening. Knowledge and hands on experience in handling of LC-MS/MS, LC-HRMS/QTOF, HPLC-SEC Required Candidate profile Knowledge of peptide characterization with and without enzyme digestion techniques. Experience in handling of large molecules, ADC’s, oligonucleotides is an added advantage
Regular Batch Analysis by using LCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS
Ensure Lab Safety Management Activities Organizing Safety Committee Meeting Responsible for Safety Training to Employees Conduct Periodic Mock Drill & Fire Drills as per Schedule Responsible for PCB activities
Responsible to Maintain and Monitoring the Daily, Weekly, Monthly Data Backup Schedules in Standalone, Servers. Managing the Vendor Qualification related to IT. Preparation & Review of IQ, OQ, PQ protocols and reports based on the requirement.
Handling of Vendor Qualification activities Handling of Document Controlling:issuing, retrieval & Archiving Involvement in Regulatory Audits Trainings to QC team on revisions of SOPs, Specifications and test procedures Documentation management system
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