Rajeev Kumar Email and Phone Number
Rajeev Kumar personal email
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I have over 17 years of work experience in the pharmaceutical sector and during the period, I have accumulated significant knowledge in the quality control, analytical research & development and Validation. I'm well-versed in the regulatory process and the numerous testing procedures that are implemented to assess the effectiveness, quality, efficacy and safety. I also have a strong background in project management and technical support and various therapeutic dosage forms like- tablet, capsule, suspension, dry powder injection and liquid injection as well as Lyophilized. The Product was Cardiovascular, Cephalosporin, Beta-lactum, Carbapenem, Analgesic, Oncological, Antiretroviral and some others.A summary of my key contributions includes: Responsible for the planning, documentation, qualification, validation, Troubleshooting, Audit, implementation, and testing such as method development. Deep understanding and expertise in chemical components, appropriate measurements of the ingredient researching and experimenting with drugs. Able to work in a pressured atmosphere and meet all the deadlines. Promote quality achievement and performance improvement throughout the organization. Set QA compliance objectives and ensure that targets are achieved. Assess the product specifications of the company and its suppliers, and comparing with customer requirements. Ensure Compliance with national and International standards and legislation. Defining quality procedures in conjunction with operating staff . Focus on employee safety and ensuring a safe work environment. Experience in Raw and Finished materials Monograph USP, BP, EP, JP and IP. Sound knowledge of ICH, PDA, FDA, WHO, TGA. MHRA and EU regulation. Identifying and resolving product defects using root cause analysis and corrective action. Excellent interpersonal and written communication skills to communicate effectively. The certificate achieved by WHO, EU, and FDA with the support of our team. I have proven ability to effectively build and maintain relationship with concern departments. Regular training programs conducted to Good Laboratory Practice as well as interpersonal skills. As per priority analyzed and release the bulk/intermediate product. Timely communicating and reporting with our senior management.
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Head Of QualityCennet Biopharma Sep 2023 - PresentHr, IndiaTotal Quality Management System, Risk Management, Gap Analysis, Corrective and Preventive Action, Audit- Internal & External (Vendor Audit), Good Documentation Practice, Training, Troubleshooting of Sophisticated instrument. Qualification of new project. New product process and method development. Validation and Technology Transfer to pilot scale-up. Related Substance, Residual Solvent and Elemental Impurity profiling. -
Head -Qc/Ard & ValidationSophal Pharmaceutical Dec 2016 - Aug 2023Hassi Ben Okba, Oran Province, Algeria Test Planning:Development of testing for raw materials, intermediates, finished products, and stability materials. Documentation:Preparation and review of protocols, Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), Specifications, Certificates of Analysis (COA), and Qualification documents. Method Development:Execution of new methods, including scale-up from pilot batches to manufacturing batches. Bioavailability and Bioequivalence:Planning and execution of studies in comparative dissolution profile compliance with regulatory requirements. Troubleshooting:Addressing issues in new and existing products using both wet chemistry and instrumental methods, with a focus on minimizing chemical waste. Validation:Preparation of method validation, process validation, cleaning validation and environmental monitoring protocols and reports in accordance with ICH guidelines. Training Programs:Conducting regular training on Good Laboratory Practices (GLP) in line with regulatory standards. Calibration Plans:Development of calibration plans for analytical instruments including UV, HPLC, LCMS, FTIR, TOC, GC, and particulate matter analysis. Stability Studies:Execution of stability studies including diluents stability, reconstitution stability, and hold time stability evaluations. Shelf Life Evaluation:Preparation and execution of stability data evaluation for determining shelf life as per regulatory standards. Standardization:Standardization of buffer solutions, test solutions, indicator solutions, and reference standards. Investigations:Investigation of Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, Corrective and Preventive Actions (CAPA), and Change Control processes.
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Quality Laboratory ManagerHospira-Pfizer Ltd. Jul 2014 - Oct 2016Visakhapatnam, Andhra Pradesh, India Validation and Training:Implementing master validation plans and conducting training sessions as per schedule. Equipment Validation and Qualification:Validating and qualifying new setups and equipment, including Design Qualification (DQ), Operational Qualification (OQ), Installation Qualification (IQ), and Performance Qualification (PQ). Calibration and Troubleshooting:Executing calibration and troubleshooting for major instruments such as UV, HPLC, GC, and FTIR. Method Validation:Conducting method validation for assay, dissolution, content, residual solvents, and related substances. Cleaning and Water Validation:Preparing and executing cleaning and water validation protocols and reports in accordance with regulatory requirements. Reference Standard Management:Preparation, execution, and control of reference and working standards. Standardization:Standardizing buffer solutions, test solutions, and standard solutions. Documentation:Preparation, review, and revision of protocols, SOPs, specifications, COAs, qualifications, Site Master Files, Quality Manuals, Safety Manuals, Quality Policies, Annual Product Quality Reviews (APQR), and stability studies. Training Programs:Conducting regular training programs on safety, SOPs, data integrity, personnel hygiene, glassware handling, analysis, and interpersonal skills in line with regulatory standards. Investigation Planning:Planning investigations for Out-of-Specification (OOS) results, deviations, change control, and CAPA in accordance with regulatory requirements. Environmental Monitoring:Monitoring and evaluating environmental conditions in production and microbiology. Documentation Control:Issuing and control of formats, SOPs, STPs, and protocols. Label Management:Issuing, controlling, and reconciling labels. Audit Compliance:Ensuring compliance during third-party audits and conducting vendor audits for raw and packaging materials (suppliers and manufacturers).
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Manager Quality ControlCyro Healthcare Pvt. Ltd. Jan 2013 - Jul 2014IndiaExecution of sampling and testing of raw materials, intermediate, finished product, packaging and stability.Preparation of method validation protocol and performance of Impurities profile, Assay, dissolution, Content, Residual Solvent and Related Substance.Execution of calibration and troubleshooting of major instrument like (UV, TOC, HPLC, GC and FTIR).Performing and execution of cleaning validation, water validation and blender validation.Preparation review and revision of new and existing Protocol, Report, SOP, STP, COA and Specifications.Preparation, execution and controlling of reference standard.Execution for shelf life of buffer solution, test solution and standard solution.Regular training programs related to Safety, SOP, Data Integrity, Personnel Hygiene, Glassware Handling, Analysis, Interpersonal skills as per regulatory aspects.Investigations of Out of specifications, Out of trend, Deviations, Change control, CAPA as per regulatory aspect. -
Quality Control ExecutivePioneer Co. For Pharmaceutical Industries Sep 2010 - Dec 2012Kurdistan, Iraq, JordanAnalysis of raw materials, intermediate, finished product, stability sample and water sample.Calibration and troubleshooting of common laboratory instrument.Perform method validation and troubleshoot of new or existing product.Performing of comparative dissolution profile with innovator.Performing analyst validation and laboratory glassware calibration.Standardization of buffer solution, test solution and standard solution.Preparation of working standard as per reference standard.Preparation and revision of new SOP, Specification and Protocol. -
Officer Quality ControlMankind Pharma Ltd Jan 2008 - Sep 2010Himachal Pradesh, IndiaSampling of raw materials, and packaging material.Routine analysis of raw materials, intermediate, finished product and stability sample. Calibration and troubleshooting of common laboratory instrument.Performing process validation sample and analyst validation.Standardization of buffer solution, test solution and standard solution.Performance of reference standard to working standard.
Rajeev Kumar Skills
Rajeev Kumar Education Details
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Bundelkhand University Up.First Division -
National Institute Of Health & Family Welfare, New DelhiB
Frequently Asked Questions about Rajeev Kumar
What company does Rajeev Kumar work for?
Rajeev Kumar works for Cennet Biopharma
What is Rajeev Kumar's role at the current company?
Rajeev Kumar's current role is Head - Quality at Cennet Biopharma Pvt. Ltd..
What is Rajeev Kumar's email address?
Rajeev Kumar's email address is ra****@****ail.com
What schools did Rajeev Kumar attend?
Rajeev Kumar attended Bundelkhand University Up., National Institute Of Health & Family Welfare, New Delhi.
What are some of Rajeev Kumar's interests?
Rajeev Kumar has interest in Formulation And Api In Pharmaceutical, F&d.
What skills is Rajeev Kumar known for?
Rajeev Kumar has skills like Usfda, Other Common Instruments Used In Laboratory, Microbial Culture, Sop, Drug Development, Ir, U.s. Food And Drug Administration.
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