Please complete the CAPTCHA to continue
A concise factual answer block for searchers comparing this professional profile.
Rajeev Kumar is listed as Head - Quality at Cennet Biopharma Pvt. Ltd. at Cennet Biopharma, based in Delhi, India. AeroLeads shows a matched LinkedIn profile for Rajeev Kumar.
Rajeev Kumar previously worked as Head of Quality at Cennet Biopharma and Head -QC/ARD & Validation at Sophal Pharmaceutical. Rajeev Kumar holds M.Sc. (Biomedical Science), Medicinal Chem, Mol Bio, Org Chem, Biochem, Inst, First Division from Bundelkhand University Up..
This section adds company-level context without repeating Rajeev Kumar's masked contact details.
Review company-level records connected to Rajeev Kumar before choosing the right outreach path.
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.
Listed skills include Usfda, Other Common Instruments Used In Laboratory, Microbial Culture, Sop, and 3 others.
Company context helps verify the profile and gives searchers a useful next step.
A career timeline built from the work history available for this profile.
Hr, India
Total 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.
Hassi 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.
Visakhapatnam, 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).
India
Execution 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.
Kurdistan, Iraq, Jordan
Analysis 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.
Himachal Pradesh, India
Sampling 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.
Activities and Societies: To Monitoring and Evaluation of health quality
Quick answers generated from the profile data available on this page.
Rajeev Kumar works for Cennet Biopharma.
Rajeev Kumar is listed as Head - Quality at Cennet Biopharma Pvt. Ltd. at Cennet Biopharma.
Rajeev Kumar is based in Delhi, India while working with Cennet Biopharma.
Rajeev Kumar has worked for Cennet Biopharma, Sophal Pharmaceutical, Hospira-Pfizer Ltd., Cyro Healthcare Pvt. Ltd., and Pioneer Co. For Pharmaceutical Industries.
You can use AeroLeads to view verified contact signals for Rajeev Kumar at Cennet Biopharma, including work email, phone, and LinkedIn data when available.
Rajeev Kumar holds M.Sc. (Biomedical Science), Medicinal Chem, Mol Bio, Org Chem, Biochem, Inst, First Division from Bundelkhand University Up..
Rajeev Kumar is listed with skills including Usfda, Other Common Instruments Used In Laboratory, Microbial Culture, Sop, Drug Development, Ir, and U.S. Food And Drug Administration.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contactsCheck these profiles if this is not the Rajeev Kumar you were looking for.
