Mukesh Tayade

Quality control manager

Talent

SurendranagarMember since September 15, 2026

HPLCGC/GCHSFTIRUV/VIS SpectrophotometerKarl Fischer AutotitraterPotentiometerPolarimeterElectrolab Tap Density TesterMelting Point ApparatusParticle SizerDissolution Test apparatusDisintegration Test apparatusChromatographyQuality ControlGLP complianceGMP21-CFR part 11Data integrityCAPAChange controlProcess validationTeam ManagementTeam buildingInstrument troubleshootingCalibration and maintenanceDocumentationWindows XPMS-Office ToolsInternet ApplicationsDocument Management system

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HPLCGC/GCHSFTIRUV/VIS SpectrophotometerKarl Fischer Autotitrater

About

Looking for a responsible position in a growing Pharmaceutical/Healthcare or similar organization which would explore my experience and potential, which will provide a wide platform for professional growth. Over 23 years of professional experience in Quality Control department of pharmaceutical industry in compliance, Maintenance, Instrumentation, Qualification, Calibration, Stability, Documentation & Team Management. (API & Formulation) Competencies in all aspects covering the analysis of Raw material, Inprocess, Finished product, Stability, Process validation. Exposure of investigations like laboratory incidents, deviation, OOS, OOT.

Exposure on 21-CFR part 11, Data integrity and QMS system. GLP compliance, documentation, Good laboratory practices. Exposure on CAPA, Change control, compliance to regulatory and customer audits. Instrument troubleshooting, interpersonal and team building skills.

Experience

Manager QC at Mepro Pharmaceuticals Pvt. Ltd. (2015-12 – Present)

Presently working at Mepro Pharmaceuticals Pvt. Ltd. Surendranagar, Gujarat (Formulation Unit). Reporting To: Head QC. Audits Faced: UNICEF, EUGMP, WHO Geneva and other customer audits.

Planning the analysis of In-process/ Finished product/Process validation samples and ensure release of material / batches within the time.
Ensure effective implementation of system and procedures as per GLP, GMP and other regulatory requirements.
Review of analytical data, reports, protocols generated in QC laboratory.
Monitor and ensure online documentation during analysis.
Review of Specification and Test procedures of inprocess/ Finished product.
Preparation/ review of SOP's in QC department.
Ensure Good documentation practices followed in QC department.
Ensure that all the instrument/ equipment's are in good working condition and timely completion of AMC's.
Ensure proper operation, Calibration and maintenance of all QC instruments as per schedule.
Manage stocks of chemicals, glassware, chromatography columns & instrument spares as required.
Ensure Qualification of analyst, qualification of working standard and instrument/ equipment's are done on time as per SOP.
Ensure availability of chemicals, reference standards, impurity standards and other consumables.
Investigate OOS /OOT results in Finish products, Stability, Raw material, packing material.
Investigate incidents, deviations in laboratory and prepare investigation report.
Initiate change control and CAPA whenever required.
Ensure 21-CFR part 11, Data integrity and QMS system is followed in laboratory and its continuous improvement.
Preparation of monthly projects in the Server system.
Review pendency of work and it's management.
Review and approval of all calibration records of instruments/ equipment's in laboratory.
Coordination with other departments like Regulatory, QA, production and stores for necessary requirements.
Internal and external audits and its compliance.
Ensure audit trial are checked & online review of data done in the server based system for correctness.
Review of COA of Finish product / Raw material/ Packing material.
Ensure water analysis and EM are performed as per set standards.
Maintain smooth and safe working environment in the laboratory.
Monitor the team performance and guide them to achieve the set goals.
Training to new and existing persons on system, SOP's and any other regulatory aspects or guideline whenever required.
Providing data to customers and regulatory agencies as per requirement.
Any other work assigned by management.

Senior Executive at Flamingo Pharmaceuticals Limited (2013-04 – 2015-12)

Worked as a raw material section incharge. Reporting To: Manager QC. Audits Faced: USFDA, MHRA and customer audits.

Responsible for work planning of raw materials, excipients and release as per requirement on time.
Responsible for Good documentation practice and follow up for sample analysis and release to meet production requirements.
Responsible for preparation & review of documents in raw material section for its complete and correctness before release.
Preparation of COA and entry of material release in SAP.
Responsible for preparation of Specification / Standard test procedures and Test data sheets of raw material & excipient.
Responsible for method transfer activity, chromatography and investigations.
Responsible for trouble shooting of instruments during any analysis of raw material section.
Responsible for online documentation by analysts.
Responsible for investigating incidents, OOS and preparing the related documents and CAPA.
Ensure smooth working in the section by following written procedures.
Training to all the analyst in raw material section and other laboratory analysts whenever required.
Ensure good condition of laboratory all the time and work in a compliant way.
Communication with R & D regarding method related issues and its rectification.
Giving answers of queries of auditors during audits if required.
Supporting to other sections related to any analysis or document review.
Handling the SAP QM module for any requisitions or preparation of masters and release of materials.

Senior Officer at Ranbaxy Labs Limited (2006-11 – 2013-04)

Reporting To: Sr. Executive