Summary
Overview
Work History
Education
Skills
Languages
Professional Summary - Current Position
Personal Information
Timeline
Generic
GANESH DATIR

GANESH DATIR

Vadodara

Summary

Having 13 years of experience in the quality control departments of the pharmaceutical industry. Madhya Pradesh FDA approved in chemical and instrumentation testing (2022). Having work experience in formulation and API. The dosage form includes sterile (injectable), tablets, capsules, derma, and MDI. Having work experience at regulatory plants of Ajanta Pharmaceuticals, Mylan, Lupin, Glenmark, and Endo Pharmaceuticals Ltd. Having approvals from regulatory authorities like the US FDA, WHO, MHRA, etc. Having experience with QMS activities in the laboratory. It involves the investigation of OOS, OOT, deviations, and incidences. Handling of CAPA, change control, and SOP revision. Ensure compliance in the laboratory. Having experience in handling different software applications like SAP, LIMS, TrackWise, MasterControl, Veeva Vault, DMS, Ample Logic, LSMP, and Compliance Wire, as well as training management software. Conducting internal inspections for QC and ensuring compliance with pre-set technical specifications.

Overview

13
13
years of professional experience

Work History

QC Manager

SUN PHARMA
Vadodara
03.2025 - Current
  • Team Leader of the GLP Section.
  • Lead a team of 10 members, ensuring high productivity.
  • Responsible for the planning and allocation of working standard qualification.
  • Responsible for HPLC column management.
  • Allocation of routine issuance of standards and columns.
  • Managed budget allocations and resource distribution for optimal project execution.
  • Managed inventory (Reference Standard, Impurities Working Standard, Chemicals, Glassware, and consumable items) levels to meet demand without overstocking, reducing waste.
  • Resolved conflicts and addressed employee concerns promptly.
  • Conducting the internal audit as per schedule.
  • Ensuring laboratory compliance in day-to-day activity.
  • Responsible for QMS investigation.
  • Coordinated training sessions using Learning Management Systems.

Asst. Manager

Endo India Par Formulations Ltd.
Indore
10.2020 - 03.2025
  • Company Overview: Endo India Par Formulations Ltd. Indore (MP) (OSD & Injectable: Raw Material, Packaging Material and Water Analysis).
  • Reporting: Sr. Manager QC.
  • Team Size: 12 Member
  • Handling of Raw Material & Packaging Material team.
  • Responsible for Timely planning and release the Raw material/ Packaging material, consumable material & Water sample as specified timeline consistent with company goals.
  • Daily planning of RM, PM and consumable sampling, work allocation of analysis of Raw Material and Packaging Material.
  • To Review & Approve Certificate of analysis of the Batches analyzed and approve the material in SAP.
  • To monitor and ensure compliance and regulatory requirements in day-to-day Quality control lab.
  • Support for detail Investigation of incidents, OOS to QMS Team.
  • Day to Day monitoring the Laboratory as per current GLP and all the activities as per regulatory environment.
  • Revisions of SOPs and looking after QMS in laboratory.
  • Help team to resolve queries raised during analysis.
  • Daily meeting with manufacturing team and SCM for Release Priority.
  • Provide technical support and training to quality control person.
  • Maintain compliance in laboratory in coordination with QA team.
  • Implementation of reduce testing for RM & PM.
  • Endo India Par Formulations Ltd. Indore (MP) (OSD & Injectable: Raw Material, Packaging Material and Water Analysis).

QA Executive

Lupin
Indore
08.2018 - 10.2020
  • Company Overview: Lupin pharmaceutical Ltd. (MDI, DERMA) Indore (MP).
  • Review of Analytical documents like Raw Material, Packaging Material, Finish Product, In-process sample, hold time sample, Stability sample, Calibration record, Analytical method validation/verification records, Analytical method transfer records etc. for completeness and correctness of the document with its audit trail.
  • Responsible for sign off 2 (Electronic data review) including audit trail of HPLC, GC, UV, IR and other software wherever applicable.
  • Review of logbooks of Standard usage, Sample reconciliation and disposition of in process samples.
  • Co-ordinate with Section head QC for analytical report release by verifying the QC observation.
  • Preparation of trending report of Analytical review error on monthly basis.
  • Lupin pharmaceutical Ltd. (MDI, DERMA) Indore (MP).

QC Sr. Officer

Glenmark Pharmaceuticals Ltd.
Aurangabad
11.2016 - 07.2018
  • Company Overview: Glenmark Pharmaceuticals Ltd. (MDI & DERMA) Aurangabad (MH).
  • Worked in Quality Control Department as QC Sr. Officer Formulation products.
  • Routine HPLC analysis including Assay, Related Substances, etc.
  • Raw Material Routine GC analysis including Assay, Residual Solvents Related Substances, etc.
  • Sampling & Analysis of Raw material and Packaging material.
  • Glenmark Pharmaceuticals Ltd. (MDI & DERMA) Aurangabad (MH).

SR. CHEMIST

Mylan Laboratories Ltd.
Nashik
03.2013 - 11.2016
  • Company Overview: Mylan Laboratories Ltd. Nasik (MH). (MNC Group)
  • Worked in Quality Control Department.
  • Sampling and Analysis of Raw material analysis Excipients & API.
  • Routine HPLC analysis including Assay, Related Substances, Residual Solvents, IR UV and chemical analysis.
  • Handling Caliber Lims software.
  • Mylan Laboratories Ltd. Nasik (MH). (MNC Group)

Ajanta Pharmaceuticals Ltd.
Aurangabad
06.2012 - 03.2013
  • Company Overview: Ajanta pharmaceuticals Ltd. (API Plant) Aurangabad (MH).
  • Worked in Quality Control Department.
  • Routine HPLC analysis including Assay, Related Substances, IR UV and chemical analysis.
  • Routine In process Sample for water content, PH, TLC.
  • Ajanta pharmaceuticals Ltd. (API Plant) Aurangabad (MH).

Education

Master Of Science - Analytical Chemistry

07.2011

Bachler Of Science - Chemistry

Pune University
04.2009

Skills

  • HPLC
  • UPLC
  • GC
  • Potentiometer
  • UV
  • MALVERN
  • UTM
  • VEEVA
  • MASTER CONTROL
  • TRACKWISE
  • LIMS (CALIBER)
  • LIMS (STAR)
  • Ample logic
  • Laboratory Standard Mana
  • Conflict resolution
  • Team leadership
  • Active listening
  • Multitasking capacity

Languages

  • English
  • Hindi
  • Marathi

Professional Summary - Current Position

Endo India Par Formulations Ltd., Indore (MP), Reporting: Sr. Manager QC, 12, Handling of Raw Material & Packaging Material team., Responsible for Timely planning and release the Raw material/ Packaging material, consumable material & Water sample as specified timeline consistent with company goals., Daily planning of RM, PM and consumable sampling, work allocation of analysis of Raw Material and Packaging Material., To Review & Approve Certificate of analysis of the Batches analyzed and approve the material in SAP.

Personal Information

  • Current CTC: 17.0 lakhs per annum
  • Notice Period: 3 months
  • Date of Birth: 12/01/87
  • Marital Status: Married

Timeline

QC Manager

SUN PHARMA
03.2025 - Current

Asst. Manager

Endo India Par Formulations Ltd.
10.2020 - 03.2025

QA Executive

Lupin
08.2018 - 10.2020

QC Sr. Officer

Glenmark Pharmaceuticals Ltd.
11.2016 - 07.2018

SR. CHEMIST

Mylan Laboratories Ltd.
03.2013 - 11.2016

Ajanta Pharmaceuticals Ltd.
06.2012 - 03.2013

Master Of Science - Analytical Chemistry

Bachler Of Science - Chemistry

Pune University

Similar Profiles

CREATE PROFILE
GANESH DATIR