Sr. Pharmacopoeial Associate - INDIAN PHARMACOPOEIA COMMISSION - Ghaziabad, U.P.
Department: Quality Assurance. Reporting to: Principal Scientific Officer (QA Division), Principal Scientific Officer (RSD Division).
- Review and Maintain the Analytical Data of IP Reference substances, Impurity Standard and PT Samples as per NABL accreditation ISO/IEC 17025:2017 and Proficiency Testing (ISO/IEC 17043:2023) and GLP
- Review the Data of Re-testing of IPRS
- To follow the Design Qualification, Installation Qualification, Operational Qualification & Performance Qualification of different Instruments & Equipments
- Preparation & Development of SOP's, STP's, Specification, Analytical Method Validation Protocol & Report
- Preparation and Implementation of Training Programme
- Approval, Control and Distribution of Quality Documents like Quality Manual, SOP's and Method of Analysis
- Review of SOPs, Non-Conformances, Deviations, Change controls, CAPA, Out of Specifications, and Repeat Analysis
- To plan, organize and conduct Self-inspections and arrange Management review meeting to ensure the implementation of proposed corrective and preventive actions
Quality Control - SUN PHARMA INDUSTRIES LTD.
(2017-04 - 2020-12)
Worked with pharmaceutical formulation units which are analysis Tablets, Capsules, Liquids, Dry Syrup, Neutraceuticals, Dry Powder Injection and External Preparation and having good knowledge as below:
- Laboratory establishment for analytical section & microbiological section
- Traceability of Documents, Instruments and Equipments
- Laboratory investigation during out of specification
- Maintenance of working and reference standard as well as reference cultures
- Instrument well versed with: FTIR, Autotitrator, G.C., HPLC, UV, IR, Viscometer, Polarimeter, Fluorimeter, Dissolution tester, Refractometer, Karl Fisher Titrator, etc. (Operation & Calibration)
- Preparation & development of SOP's, STP's, Specification, Stability Protocol & Report, Analytical Method Validation Protocol & Report, Analytical Report, COA etc.
Quality Control - RANBAXY LABORATORIES LTD.
(2012-10 - 2017-03)
Worked with pharmaceutical formulation units which are analysis Tablets, Capsules, Liquids, Dry Syrup, Neutraceuticals, Dry Powder Injection and External Preparation and having good knowledge as below:
- Laboratory establishment for analytical section & microbiological section
- Traceability of Documents, Instruments and Equipments
- Laboratory investigation during out of specification
- Maintenance of working and reference standard as well as reference cultures
- Instrument well versed with: FTIR, Autotitrator, G.C., HPLC, UV, IR, Viscometer, Polarimeter, Fluorimeter, Dissolution tester, Refractometer, Karl Fisher Titrator, etc. (Operation & Calibration)
- Preparation & development of SOP's, STP's, Specification, Stability Protocol & Report, Analytical Method Validation Protocol & Report, Analytical Report, COA etc.
