Vijetha V. Email & Phone Number

Dubai, Ae

Dubai, United Arab Emirates

Dubai, United Arab Emirates

India

 Responsible for implementing and coordinating consistent quality management and improvement process. Quality inspections and testing of raw materials, finished products (paracetamol tablets and solution) and packaging and labeling. Handling review and control of key quality processes like Deviations, CAPAs and Change controls. Review and control of study protocols, reports, workbooks, employee training records, BMRs and OOS investigations. Development, review and update… Show more  Responsible for implementing and coordinating consistent quality management and improvement process. Quality inspections and testing of raw materials, finished products (paracetamol tablets and solution) and packaging and labeling. Handling review and control of key quality processes like Deviations, CAPAs and Change controls. Review and control of study protocols, reports, workbooks, employee training records, BMRs and OOS investigations. Development, review and update and control of Standard Operating Procedures. Maintenance and co-ordination of the documentation and archiving system. Conducting internal audits of facilities and providing support for audits. Participating in continuous quality improvement activities.Achievement: Key contributions identifying, proposing and implementing new improvement plans that lead to improvement in staff time management and performance. Show less

Guildford, United Kingdom

 Pre-formulation development, Prototype development, analytical development, packaging development, ICH stability studies in line with study plans, timelines, testing protocols, and GxP regulations. Preparation of experimental, preformulation, formulation samples and formulation batches for clinical studies (Gel, Cream, Ointment, Aerosols) as per the allocated project plan, protocol or formula. Weighs, mix, process to produce experimental trial samples, pilot and small scale batches… Show more  Pre-formulation development, Prototype development, analytical development, packaging development, ICH stability studies in line with study plans, timelines, testing protocols, and GxP regulations. Preparation of experimental, preformulation, formulation samples and formulation batches for clinical studies (Gel, Cream, Ointment, Aerosols) as per the allocated project plan, protocol or formula. Weighs, mix, process to produce experimental trial samples, pilot and small scale batches gels, creams, ointments and sprays as required. Records observations on product, process characteristics and product stability during experimental trials and scale up batches as required.  Recognize out of normal experimental situations and design experiments to trouble shoot problems, provides feedback to the supervisor and seeks assistance as required. Preparation of project reports like study results and conclusion, analysis of experimental data. Calibration and maintenance of laboratory equipment in line with GxP regulations. Report any amendments and deviations and assist with investigation and internal audits with the quality department.  Contribute to the preparation of SOPs and Forms. Documentation archiving. Adhere to and work in accordance with Health & Safety Policies and COSHH regulations. Show less

Loughborough, United Kingdom

 Project objective: An investigation into Dimethyl Sulfoxide (DMSO) toxicity: To check the %viability of human Osteoblast cells when frozen/thawed in different concentrations of DMSO and when exposed to 10% DMSO for different time period.  Skills Acquired: Human Osteoblast Cell Culture, maintaining master cell bank and working cell bank, DMEM medium preparation, Cryopreservation of mammalian cells-freezing and thawing, independently carried out the research, data recording and generated… Show more  Project objective: An investigation into Dimethyl Sulfoxide (DMSO) toxicity: To check the %viability of human Osteoblast cells when frozen/thawed in different concentrations of DMSO and when exposed to 10% DMSO for different time period.  Skills Acquired: Human Osteoblast Cell Culture, maintaining master cell bank and working cell bank, DMEM medium preparation, Cryopreservation of mammalian cells-freezing and thawing, independently carried out the research, data recording and generated results and future recommendations. Show less

India

 Perform chemical and physical analysis of raw materials and finished products and packing materials used for solid dosage form like tablets, capsules, dry syrup and dry powder injectable by using wet chemistry, HPLC. Testing of solid pharmaceutical dosage forms using techniques of dissolution, disintegration, and friability. Documenting work process and test results in compliance with quality standards. Maintenance and co-ordination of the documentation system. Calibration… Show more  Perform chemical and physical analysis of raw materials and finished products and packing materials used for solid dosage form like tablets, capsules, dry syrup and dry powder injectable by using wet chemistry, HPLC. Testing of solid pharmaceutical dosage forms using techniques of dissolution, disintegration, and friability. Documenting work process and test results in compliance with quality standards. Maintenance and co-ordination of the documentation system. Calibration of laboratory equipment with established and validated calibrating procedure. Quality check of finished products before and after packaging. Performing all the analysis according to cGMP and ISO 9001 standards. Show less

Thiruvananthapuram Area, India

 Cell culture and maintenance of HeLa cells lines for the project. Preparation of media, controls, reagents and buffer for the ongoing projects Drug addition and Removal of maintained cell lines and preparation of these samples for analysis Preparation of samples- immunostaining for Flow cytometry analysis and Confocal microscopy.  Assist in interpretation of results obtained from experiments and preparation of reports.

Thiruvananthapuram Area, India

 Project Objective: Reversibility of the effect of DAT1, a potential anticancer agent, in cervical cancer cells (HeLa cells) Skills Acquired: Mammalian (HeLa) Cell culture, Drug addition and Drug removal, Immunostaining, Flow Cytometry and FACS analysis, Immunofluorescence and Confocal microscopy analysis of cells, analyzing data with minimal supervision.

Master Of Science (Msc), Pharmaceutical Engineering

Modules: Drug Delivery and Targeting, Separations and Downstream Processing, Cell based Therapies, Colloidal Engineering and Nano-science.

Bachelor Of Technology (B.Tech.), Biotechnology And Biochemical Engineering

Modules: Industrial Microbiology, Bio-process Technology, Engineering Mathematics, Heat and Mass transfer Operations, Bio-process Design.