Mahendra Kumar Khandelwal

• Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
• Knowledgeable [Desired Position] with proven history of managing teams and improving operational efficiency. Successfully implemented processes that enhanced productivity and streamlined workflows. Demonstrated leadership and problem-solving skills in challenging environments.
• Admire in Quality Control System as a Deputy Manager Profile Experience as QC professional in across the RM, FP & PM with leadings pharmaceuticals companies, Responsible for GLP activity in quality control laboratory. Expertise in handling of all analytical instrument with upgraded software system Adherences with current regulation applicable for Analytical Laboratories & their implementation. Pharmacopoeia review for compliance with upgraded standard, general information & product monograph. Training on GLP & trouble shooting. Data analysis & trending for statistical evaluation.

• Analysis of bulk drugs (API) intermediate & fine chemicals.
• Analysis of all finished solid dosage products as Tablets & Capsules.
• Analysis of all liquid dosage as Injection & Suspension.
• Analytical handling of sophisticated Instruments: High Performance Liquid Chromatography (Shimadzu, Agilent, Dionex, Waters), Gas Chromatography (Agilent, Shimadzu-headspace), Infrared Spectrophotometer (FTIR), UV- Spectrophotometer (Shimadzu), Karl Fischer (Metrohm), Potentiometer (Metrohm).

• Executive, Mankind Pharma, Paonta Sahib, Paonta Sahib, H.P., 08/01/18, Present, Validation of finish oral solid dosage analytical method as well API & Excipient analytical method., Compilation of validation data and preparation of AMV report., Handling of QC related QMS activity such as change control, Incident & quality events., Review of OOS/OOT investigation report and assessment of probable cause related to laboratory error., Monitoring of calibration activity for QC instruments & review of executed calibration records including OOC., Trouble Shooting & Co-ordination with External Vendor for Preventive Maintenance., Audit trail review for other analysts related to finish dosage and other incoming materials testing., Provide the feedback to investigation about analytical queries asked during the audit/inspection., Submission of executed record to QA for review and support for any incomplete documentation as per review-check., Support to team for preparation of analytical method as per validated method for implementation., Review of QC functional SOP’s for any correction based on pharmacopeial amendments or as per proposed CAPA.
• Officer, Amneal Pharma Pvt Ltd, SSE, Ahme_aaa_, Ahme_aaa_, 07/01/17, 07/31/18, In-house Calibration, Trouble Shooting & Co-ordination with External Vendor for Preventive Maintenance., Inspection & Testing of Incoming API, Excipient & Finish Formulation (OSD)., Expertise in handling of Critical Analytical Activity- Such as Related Substances, Assay, Residual Solvent on HPLC/GC., Actively involved in GLP related functional- such as Qualification of Working standard, Maintenance of Ref. Standard., Review of Raw data, Analytical Report, Calibration Report, OOC Record, Instrument Uses Log, Incident investigation., Verification of analytical method after tech transfer from ADL team and review of draft analytical method., Audit trail review as authorised deputy in absence of directly responsible personnel as additional responsibility., Preparation of training needs identification (TNI) and training plan for individual as per QC functional matrix., Perform the solution and reagent shelf life study (Validity Period) as per approved study base protocol., Preparation of analytical protocol, calibration protocol, qualification protocol & SOP’s related to QC functional., Retrieval verification of back-up data, maintenance of control copy issued to QC, Review of external reference certificate provided by vendor such as temperature mapping report, traceability certificate etc., Provide the feedback to investigation about analytical queries asked during the audit/inspection., Submission of executed record to QA for review and support for any incomplete documentation as per review-check., Support of OOS and OOT Laboratory investigation by conducting re-testing, hypothesis plan, re-analysis, sampling integrity to identify the laboratory error or probable cause as part of Phase-I Laboratory Investigation., Trending of laboratory incident, out of specification, Change Control, planned deviation on quarterly basis.
• Sr. Executive, CIPLA Ltd, Pithampur, Indore, M.P., 07/01/15, 06/30/17, Performed all type of qualitative as well as quantitative analysis of finish dosage and APIs., Key assignment are handling of chromatographic techniques analysis such as HPLC & GC., Calibration of Gas Chromatograph as Well Liquid Chromatographic System., Trouble Shooting in case of malfunctioning of instrument., Online recording and documentation of testing raw data in accordance with data integrity policy & GDP., Responsible for Deviation Control; by following the written SOP’s, manual instruction, adherence with written procedure, regular training & effective monitoring., Key member of the Investigation & Document Control team, responsible for significant evaluation of corrective action & preventive action., Monitor the all type of QC activity & review of executed report, Issuing & archiving daily records & documents, Handling of multi stages products related OOS, OOT, & related investigation.

H.No. 256/9/1, Nav vihar colony, Ward No. 12, Paonta Sahib, Dist-Sirmour (H.P.).

Pin- 173025

• Father's Name: Mr. Sukh Ram Khandelwal
• Date of Birth: 06-07-1981

• Love to read Knowledgeable books which enhance my Knowledge in my profession as well as my social life.
• listening songs.