Hemant Jadhav

Dosage Form: OSD, Injectable, Ointment, Liquid oral, Dry Syrup

• Handling Quality Control department since 16 May 2025.
• Ensuring QC policies are implementing effectively.
• Ensuring the materials / products were released within stipulated time frame.
• Review of departmental / cross departmental documents.
• Involved in investigations to identify Root cause and to take CAPA.
• Imparting training on various guidelines.
• Ensuring no data integrity

Dosage Form: OSD, Injectable, Ointment

• Handling Quality Control department independently.
• Maintaining the department in compliance mode 24 x 7 Hrs.
• Successfully handled various regulatory audits.
• Empowering employees to get the best from them.
• Ensuring timely release of RM/PM/FP/ stability samples.
• Review of SOP, validation protocols / Reports, stability summery report, investigation reports.
• Ensuring timely completion of calibration and preventive maintenance of equipment’s.
• Review of PQR documents, site master file, validation planner and reports
• Procurements, installation and qualification of instruments.
• Involved in QC software validation.

Dosage Form: OSD

• Responsible for Raw Material, Packaging Material and Microbiological sections.
• Overall responsible for finished product, Stability, Process validation work.
• Maintaining the GLP 7 X 24 hrs. in Quality Control Department
• Review/Release of RM/PM/Micro/Stability COA
• Expertise to conduct investigation and identify root-cause Conducting and drafting the Investigations
• Review of process validation protocols/Equipment Validation protocols. Imparting the trainings to subordinate.
• In depth knowledge of stability.
• Faced regulatory audits in various company at different position.
• Understanding the requirements of Quality.
• Ability to handle data integrity issues.
• Knowledge of sophisticated instruments.
• Micro planner.

Dosage Form: OSD

• Handling Global stability department
• Communication with various sites of Actavis related to stability issues.
• Ensuring stability samples loaded in timely manner after verification of data logger record for overseas samples
• Ensuring timely withdrawn of stability samples from chamber for analysis.
• Planning of analysis, preparation/review of stability summary report.
• Performing investigations of Incidents, OOS and OOT as and when required
• Imparting trainings on various topics.
• Review of stability protocol, SOP, Specifications and Method of analysis.

• Dosage form: OSD, Parenteral

• Plan, Co-ordinate with review team to review of analytical data, stability summary report.
• Data Review of process validation Batches
• Review of Calibration of equipment’s data,
• Reviewed of stability chamber management data.
• Ensure the accuracy and correctness of Documents
• Handling of OOS s OOT Documents.
• Drafting investigation reports and suggesting CAPA.
• Imparting training to the analyst and reviewers.
• Handling Softwares like Empower, stability solution, Trackwise.

Dosage Form: OSD, Injectable, Ointment, Transdermal, Aerosol, Soft Gel

• Group leader for Post product stability department
• Finished product Planning
• Charging of stability samples in stability chamber as per storage conditions
• Withdrawal of stability samples as per schedule
• Execution of stability samples,
• Preparation of stability protocol
• Review of analytical Data.
• Performing investigation
• Preparation of OOS and OOT investigation report

Dosage form: OSD, Parenteral

• Looking after QA and QC, planning of work.
• Preparation of Site Master file, preparation of SOP.
• Preparation of process validation protocol,
• Handling of Market complaints.
• Preparation of Training manual, internal audit and IPQA activity.
• Review pharmacopoeia and update specification.
• Validation of instrument, calibration of equipment’s,
• Review of method of analysis.
• Ensuring release of RM /PM/In-process / FP samples.
• Performing stability study.

Dosage from: Liquid Oral

• Handling QC department.
• Ensuring timely release of RM / PM /FP samples.
• Performing analysis of liquid oral products, raw materials and packing materials.
• Preparation of specification and Method of analysis

Dosage form: OSD, Parenteral, Liquid Oral, Dry syrup

• Performing analysis of Raw materials, packing materials, finished product like, Injection, liquid oral and Capsule.
• Performing sterility, Bio burden for water and finished product.
• Performing pyrogen testing.
• Operation of various equipment's

Dosage Form: Parenteral (SVP and LVP)

• Performing raw materials, packing materials and finished product analysis.
• Performing sterility and MLT testing.
• Performing pyrogen testing
• Performing toxicity testing.