Sr.Development & Validation Analyst
Saudi pharmaceutical industries & medical appliances
Total des années d'expérience :12 years, 5 Mois
R & D Senior Analyst with strong background in Analytical instrument and excellent accomplishments in the fields of pharmaceuticals for method development and method validation for product, analysis, etc. one publication in international refereed journal. Considerable experience of managing analytical laboratories instrument,
Core Competence: Chromatographic analytical techniques (HPLC, Gas Chromatography, UV Spectroscopy), analytical method development, scientific projects and execution, documentation of analytical laboratories. Involved in R&D process and assisting and carrying out method development and validation of pharmaceuticals product. Handling the equipment’s like HPLC(Reversed-phase, Normal phase chromatography), UV-visible spectroscopy, GC, Lyophilizer, Karl-Fischer, (AktaPurifire, Aktapilot from GE Healthcare), FTIR, Titrino plus (Metrohm-848) Potentiometer, DT, Bulk Density apparatus, Melting Point apparatus, Autotitrator, viscometer, sieve shaker, Auto analyser, COD/BOD Reactor etc.
Good analytical data interpretation skills. Mainly Assay, Dissolution, RS, Performing activities according to the GMP/GLP safety requirements related to the assigned activity.
Analysis of Raw Materials, In-Process, stability& finished product by using instrumental & conventional methods. Documentation and report compilation.
Performing duties related to Corrective and Preventative Action (CAPA) plans, deviations and Change Control (CC).
Participating to schedule or execute validation activities and designing validation plans.
Stability Study for drug substance and drug product long term and stress study sample.
In-Process analysis and method validation according to ICH guideline.
Very good execution of laboratorial analysis as per GLP.
Good hand on analytical documentation like MVR, MVP, and STM etc.
Enzymatic assay like amylase, cellulose, urease, xylanase, etc
Successfully faced MHRA Audits, WHO, FDA, ISO, MOH and African countries audits, and internal audits.
Chromatographic analytical techniques (HPLC, Spectroscopy, Gas Chromatography),
analytical method development and validation for biosimilers, scientific projects and execution, documentation of analytical
laboratories.
Processing and Analyzing Insulin samples in different production stages and through different
analytical test, involved in technology transfer of R&D process and assisting production personnel in
carrying out validation of the drug product, Method development And Check the blood sugar level
by Invitro or Invivo study. Handling the equipment’s like HPLC, GC, Karl-fischer, AktaPurifire,
Aktapilot, FTIR, UV Spectrophotometer, Titrino plus (Metrohm-848) Potentiometer, Dissolution
apparatus, DT, Friability apparatus, Hardness tester, Moisture analyzer, BD apparatus, MP
apparatus, Autotitrator, viscometer, sieve shaker, Autoanalyser, COD/BOD Reactor apparatus etc.
And calibration of lab equipment’s.
Preparation and maintenance documentation like raw & finish registers, volumetric, indicator,
general reagent, register and protocols of Raw & finish product analysis
Good analytical data interpretation skills. Mainly Assay, RS, dissolution and particle size
determination.
Performing activities according to the GMP/GLP safety requirements related to the assigned
activity.
• Water purification and chemical analysis of soft & hard water, chlorine content, total dissolve solids.
• Estimation and determination of protein, carbohydrate, lipid, enzyme etc.
• Chemical and Biochemical oxygen demand of waste water and sludge.
• Soil and sludge sample analysis and check the fertility of the soil.
• Soil treated by microbial consortium and checks the quality of the soil sample.
• Project Management and Handling of equipments, fermentation of microbial products.
• Documentation and report compilation
• Knowledge of validating processes like fermentation, purification using chromatography techniques etc.
• Research in the area of microbial fermentation of agricultural, and food industry processes and petrochemical industries or fisheries industries etc
• Microbial fermentation of oil degrading bacteria and its product processing.
Working as a Quality control Analyst at Flamingo Pharmaceuticals Ltd. Taloja Navi Mumbai.
• To perform and implement quality control testing and analysis of RM/Finish goods, validation samples
• Sampling of raw material as per the Standard Operating Procedure
• Analysis of water from different point in the plant.
• Preparation and standardization of volumetric solution
• Calibration of apparatus including melting point apparatus, TD/BD apparatus, pH meter, conductivity meter, and FTIR, Karlfischer, potentiometer.
• Handling of all equipment of QC Lab for Quality check of production and packing samples
• Timely completion of the records of quality control & filling the data in SAP System
• Handling of equipments like HPLC, TLC, Dissolution apparatus, DT, Friability apparatus, FTIR, UV Spectrophotometer, Hardness tester, Moisture analyser, BD apparatus, MP apparatus, Autotitrator, viscometer, sieve shaker, etc.
• Calibration of QC Lab equipments,
• Preparation and maintenance documentation like raw & finish registers, volumetric, indicator, general reagent, register and protocols of Raw & finish product analysis
• Plant water testing as per the SOP
Successfully faced MHRA Audits, WHO, FDA, ISO, and African countries audits. Internal audits.
Technical skills
• Good preliminary knowledge analytical procedures and documentation.
➲ M. Sc ( Biochemistry) Shri Shivaji College of Science Akola AGREGATE- 67%