Monu Chaudhary
Modinagar,Uttar Pradesh
Summary
Highly skilled analytical chemist with extensive expertise in HPLC, Gas Chromatography, Dissolution Tester, UV-Visible Spectrometer, Disintegration Tester, and Hardness Tester. Proficient in Microsoft Office, Empower software and SAP. Adept at utilising advanced laboratory techniques to ensure precise and accurate results. Committed to continuous professional development and contributing to innovative research within the field of analytical chemistry.
Detail-oriented Deputy Manager with nearly 14 years of experience in pharmaceutical product analysis within highly regulated environments. Manages laboratory compliance, oversees QC report approvals, and supports regulatory operations for timely submissions. Drives improvements through gap analysis and ensures robust audit readiness while leading quality assurance initiatives.
Overview
14
14
years of professional experience
Work History
Deputy Manager
Alder Biochem Pvt. Ltd.
Dehradun, Uttarakhand
12.2023 - Current
- Responsible for planning, execution, troubleshooting, training and related work of lab compliance.
- Track, review, approve & support to timely completion and Release the all qc Report.
- Support Regulatory Operations for submissions, including timely submission of stability data, data retrieval during inspections, and statistical trending of stability data.
- Responsible for the overall compliance w.r.t. the preparation, review and conclusion of Specifications, STPs and GPs for all Finished Products and Raw Materials incompliance with Regulatory approvals, SOPs and respective Pharmacopoeias.
- Expertise to handle the quality impacting deviations, impact assessment, technical Investigation as team leader.
- Functional expertise in handling of product/process risk-based approach, trouble shooting, deviations.
- Handling of change control, OOS, non-conformance, Temporary change control (deviation) as per life cycle, complete Investigation and CAPA handling through manual/automated system - Caliber system, track wise including effectiveness monitoring.
- Identification of area for improvement through gap analysis in line cGMP requirement & maintain online compliance, data integrity issue monitoring. Worked with multiple international consultants for GAP assessment.
- Collaborate with the laboratory management team to prepare for and host internal and external auditors, and coordinate timely closure of audit observations.
- Actively participate in safety initiatives and ensure compliance with safety and other statutory requirements.
- Led contract manufacturing operations for premium soft gel products
Asst. Manager
Dishman Carbogen Amics Ltd.
Ahmedabad
06.2022 - 12.2023
- Lead the Finish Department in performing routine chemical and physical testing of oral solid dosages, pharmaceutical materials/ingredients, and finished products.
- Oversee overall operations in the finish section of Quality Control, including work planning, sampling, testing, review, sample allocation for finished products, and issuance of work sheets.
- Maintain and ensure cGMP/cGLP compliance within the Quality Control Department.
- Review specifications, standard test procedures, and standard operating procedures, as well as test data sheets, analytical method transfer protocols, and analytical method transfer reports.
- Ensure the use of PPE and implement lab safety protocols.
- Ensure the availability of required reference standards, working standards, primary standards, impurity standards, and chemicals for testing and day-to-day customer requirements.
- Actively participate in safety initiatives and ensure compliance with safety and other statutory requirements.
- Review and ensure timely release of in-process, intermediate, cleaning samples, and drug substances according to respective specifications and standard test procedures.
- Ensure housekeeping, laboratory cleanliness, and adherence to shift procedures in QC.
- Review analysis results from contract laboratories.
- Perform and ensure all QC lab operations are conducted according to written procedures.
- Directed manpower allocation and ensured optimal equipment and instrument utilisation
- Ensure all instruments are qualified and calibrated at the time of use, update the master calibration schedule, and coordinate maintenance and service in case of breakdowns.
- Ensure high-quality analytical results and documentation are generated in a timely manner.
- Participate in analytical investigations of out-of-specification (OOS) results, examine results, and initiate change control requests when necessary, generate deviation reports, determine root causes, and provide recommendations for corrective actions.
- Plan, execute, troubleshoot, train, and manage lab compliance activities.
- Demonstrate time management and project organization skills.
- Review all system-related documents, such as analytical data, protocols, reports, and Certificates of Analysis (COAs).
- Review and track non-conformances and quality control data as required by laboratory quality assurance procedures.
- Collaborate with the laboratory management team to prepare for and host internal and external auditors, and coordinate timely closure of audit observations.
- Proactively involve in daily planning for production to support business continuity plans.
- Led drug development projects and enhanced patient care globally
Executive
Sun Pharmaceutical Industries Ltd.
Guwahati
07.2016 - 05.2022
- Previously handling and leading AQA and lab compliance.
- Participation in Quality management system (i.e. Change management, Incident/Deviation/market complaint/OOS/ OOT/CAPA etc.).
- Track, review, approve & support to timely completion of all CCRs/ Deviations/OOS and investigations related to product release/Quality System/Procedures to ensure on-time closure of complaints/Deviations/ OOS/ investigation.
- Responsible for planning, execution, troubleshooting, training and related work of lab compliance.
- To ensure compliance to cGMP, review and track non-conformances and QC data as required by laboratory QA procedures. Immediately communicate significant concerns identified to QC Head, QA Head and Site Quality Head to ensure that questionable test results are not released. Ensuring the implementation of CAPA.
- To review the change control, deviation, CAPA, OOS, OOT Lab event task received from QC in track wise software supporting unit QA in batch disposition decision for batch under investigation for OOS/OOT test results based on laboratory investigation, manufacturing investigation, and history of materials/product, trend of batches and reliability of manufacturer.
- Review all system related documents such as protocols, reports and agreements.
- To ensure and monitor the compliance for policies of systems and configuration control of application software in order to meet with 21 CFR Part 11 and implementation of data backup/archival.
- Proactively manage and develop talent in initiation of specifications/STPs field and influence and motivate key stakeholders for successful implementation of plans and aligning the same with organization goals.
- Review Change control, Lab Event and OOS/OOT investigation reports as and when required.
- Review and track non-conformances and quality control data as required by Laboratory quality assurance procedures.
- Review the methods transfer documents.
- Work with laboratory management team to prepare for and host internal and external auditors. Assists laboratory management team to ensure timely closure of audit observations.
- Participates in Management Review Meetings and other Quality Team Meetings.
- Coordinated with R&D for product variation approvals
- Spearheaded international pharmaceutical product launches in India and the United States
Sr. Executive
Zydus Cadila Healthcare Ltd.
Sikkim
03.2015 - 07.2016
- Execution of Stability Study Protocols for validation batches, revisions to established marketed product, annual addition batches, and batches charged on stability as a result of process deviation and any other batch deemed necessary to be charged on stability by QA.
- To participate with supervisor to close the investigation for deviation, Incidents, OOT and OOS.
- Review of stability protocol, stability monthly plan and approval of stability chamber daily temperature log reports.
- Support Regulatory Operations for submissions, including timely submission of stability data, data retrieval during inspections, and statistical trending of stability data.
- To investigate and review of OOS, OOT and lab incidences within the stipulated time.
- To ensure the compliance against the CAPA proposed.
- Review of Change Control, Lab Event and OOS/OOT investigation reports from QC aspects as and when required.
- To ensure compliance for Commercial and Exhibit stability program and related activities to cGMP Standards and review the stability analysis trend data.
- To ensure the compliance with the in-house/Pharmacopoeia methods and specification limits in testing and disposition of raw materials.
- Initiation of change control request with respect to change in Specifications, Standard Test Procedure (STPs) and General Procedure (GPs) in Documentum Compliance Manager (System Software).
- Responsible for the overall compliance w.r.t. the preparation, review and conclusion of Specifications, STPs and GPs for all Finished Products and Raw Materials incompliance with Regulatory approvals, SOPs and respective Pharmacopoeias.
- To ensure 100% effective and timely revision of all documents (specifications/STPs) on the basis of the queries raised by internal/external customers.
- Issuance of controlled copies of specifications/STPs/GPs to the QC department for analysis and uncontrolled copies to Regulatory Affairs, GMS and QP of respective sites on request basis.
- Plan own work and the work of others and lead work groups or teams, when needed, to familiarize yourself to changing priorities, meet deadlines, and work well under pressure.
- Exercise initiative and judgment as well as make decisions within the scope of assigned.
- Proactively managed and developed talent in specifications/STPs sector
- Review and approve QC test results and report to determine whether the test.
- Review and track non-conformances and quality control data as required by Laboratory quality assurance procedures.
- Review and approve methods transfer documents.
- Work with laboratory management team to prepare for and host internal and external auditors. Assists laboratory management team to ensure timely closure of audit observations.
- Active participant in management and quality meetings
- Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Asst. Officer
Akums Drugs & Pharmaceuticals Ltd.
Haridwar
02.2014 - 03.2015
- Analysis of the Raw Materials for the various formulations.
- Analysis of Finished Products and In process of Tablet, Capsule, Dry injection and Dry Syrup.
- Updating Specification of Finished Products and Raw Materials.
- Coordination with QA, and Production Dept.
- Online Documentation includes Maintaining calibration Records.
- Updating of instrument logs, Preparation of C.O.A's.
- Preparation, of Working standards and maintain the record for the same.
- Calibration of Analytical Instruments.
- Analysis of Finished Products and In process of Tablet, Capsule, and Liquid Syrup.
- Review and Updating Specification of Finished Products and Raw Materials.
- Conducted training activities following SOPs
- Coordination with QA and Production Dept. Online Documentation includes SAP release of Materials and other applications of SAP.
- Weekly planning of the analysis activities.
- Preparation, monitoring of Working standards and maintain the record for the same.
- Analysis of Water as per IP/BP/USP/EP standards.
- Receiving Quotations/Functional design specifications from the suppliers and vendors for ordering Instruments / Equipment's in Q.C.
- Raising C.E.R, along with necessary documentation viz. URS and DQ.
- Qualification of Equipment/instruments including FAT, SAT, IQ, OQ, PQ and Handover Certificate.
- Monitoring and supervision of Analysis of finish products (PFS, FFS, Aerosol and Tablet/Capsule formulations) as per pharmacopoeia, monographs and In House methods.
- Reviewed and updated STPs, EOPs, IOPs, QCPs and SOPs for accuracy and compliance
- Akums Drugs & Pharmaceuticals Ltd, Haridwar, (India) is the largest contract manufacturing pharmaceutical company of India. The organization deals in the manufacturing and export of formulations in a wide spectrum of dosage forms & therapeutic segments.
QC Chemist
Pro Lab Pvt. Ltd.
Roorkee
01.2012 - 02.2014
- Receiving Quotations/Functional design specifications from the suppliers and vendors for ordering Instruments / Equipment's in Q.C.
- Responsible for analysis of raw materials, in process, intermediate, finish product, stability samples, hold time samples.
- HPLC & Chemical analysis of Raw Materials, in process and finish products.
- Stability sample analysis and summary preparation.
- Preparation and standardization of volumetric solution and maintain its records.
- Maintain chemicals inventory and raise PO whenever required.
- Preparation STPs & SOPs.
- Daily verification of analytical balance.
- Daily calibration of pH and conductivity meter.
- Calibration of Instruments.
- Responsible analysis for stability samples, summary preparations, submission of data to regulatory requirement.
- Analysis of the Raw Materials for the various formulations.
- Analysis of Finished Products and In process of Tablet, Capsule, Dry injection and Dry Syrup.
- Updating Specification of Finished Products and Raw Materials.
- Coordination with QA, and Production Dept.
- Online Documentation includes Maintaining calibration Records.
- Updating of instrument logs, Preparation of C.O.A's.
- Preparation, of Working standards and maintain the record for the same.
- Calibration of Analytical Instruments.
- Analysis of Finished Products and In process of Tablet, Capsule, and Liquid Syrup.
- Review and Updating Specification of Finished Products and Raw Materials.
- Training activities as per SOP's.
- Coordination with QA and Production Dept. Online Documentation includes SAP release of Materials and other applications of SAP.
- Weekly planning of the analysis activities.
- Raising C.E.R, along with necessary documentation viz. URS and DQ.
- Qualification of Equipment/instruments including FAT, SAT, IQ, OQ, PQ and Handover Certificate.
- Monitoring and supervision of Analysis of finish products (PFS, FFS, Aerosol and Tablet/Capsule formulations) as per pharmacopoeia, monographs and In House methods.
- Preparation and Review of S.T.P's/ E.O.P's/ I.O.P's/ Q.C.P's and SOP's.
- The success story of Pro Laboratories Pvt. Ltd. was scripted by a group of young entrepreneurs. Today, Pro Laboratories has the facilities to manufacture liquid orals, tablets, and capsules.
Education
Master of Science - Biotech
ITS Paramedical College
2013
Bachelor of Science - ZCB
C.C.S. University
2009
Skills
- HPLC
- Gas Chromatography
- Dissolution Tester
- UV-Visible Spectrometer
- Disintegration Tester
- Hardness Tester
- Proficient in Microsoft Office, Empower software and SAP
Accomplishments
- Successfully faced audits of WHO, ISO, CQA, EU, EDQM.
- Successfully implemented online calculation for ASSAY, DISSOLUTION.
- Certified for outstanding contribution in closing all legacy stability samples testing.
Languages
Hindi
English
Timeline
Deputy Manager
Alder Biochem Pvt. Ltd.
12.2023 - Current
Asst. Manager
Dishman Carbogen Amics Ltd.
06.2022 - 12.2023
Executive
Sun Pharmaceutical Industries Ltd.
07.2016 - 05.2022
Sr. Executive
Zydus Cadila Healthcare Ltd.
03.2015 - 07.2016
Asst. Officer
Akums Drugs & Pharmaceuticals Ltd.
02.2014 - 03.2015
QC Chemist
Pro Lab Pvt. Ltd.
01.2012 - 02.2014
Master of Science - Biotech
ITS Paramedical College
Bachelor of Science - ZCB
C.C.S. University