ACHYUT JAGDHANE

• Responsible for smooth functioning of entire QC activities
• Approving all SOPs as per the defined procedure
• Ensure that CA/PA for Nonconforming Products
• Recording Customer Complaints as per defined SOP
• Verification of RM and FG.
• Analysis of Raw materials, In-process material and Finished products
• Identify training needs as per gaps in performance
• Adherence to Training Plan/ Carrying out Inductions for newcomers.
• · Ensuring AMCs for all lab instruments.

• To set up a New Quality control lab for regulatory compliances·
• To design a functional quality control lab as per standard operating procedures.
• Analytical Method development
• Analytical Method validation.
• Stability studies
• Technology transfer

1. Complete analytical support for conceptual studies for formulation development .

2. Analytical Method Validation as per regulatory requirements .

3. Technology Transfer as per regulatory Guidelines .

4. Analytical Method development as per the requirement of formulation for Assay & RS

5. Stability testing ,protocol design ,long term stability tests ,Drug product stability testing , data trending , forced degradation studies & photo stability studies

1`.Overall Supervision of Quality Control laboratory for to maintain the laboratory in an inspection ready state .
2. Interacting with all other departments throughout the organization.

3. Ensuring Proper Investigation of Incidents, deviations, OOS (Out of Specification results), OOT (Out of Trend results) and CAPA (Corrective action and Preventive action) Implementation.
4 . Responsible for to Develop, optimize, validate and troubleshoot analytical test methods as required.
5. To Ensure adequate facilities, Instruments, Trained Personnel, Approved procedures for testing of raw materials, Packaging materials, In-process, Finished Products and Stability

testing Samples.
6. Ensuring the Qualification, Calibration, Preventive maintenance of Instruments/Equipments.
7. Responsible for to Draft written test procedures for new analytical methods.

8. To Review and Approval of Specifications, Standard Testing Procedures, Protocols for Stability Studies, Process Validation, Cleaning Validation. .
10. Ensuring the proper maintenance of samples for testing like API (Active Pharmaceutical Ingredients) , Excipients, Packaging materials, In Process samples, Finished Products, Stability samples and Water samples as per their storage Condition in the respective designated places.
11 . Monitoring the Analytical method transfer activities of drug substances, drug products and Excipients whenever required before taking exhibit batches

1) Monitor analytical activities & Experiments in support of Method development , method validation , compatibility studies and stability tests as per EP, USP & ICH guidelines

2) Stability testing ,protocol design ,long term stability tests ,drug substance stability testing , comparator stability testing , data trending , forced degradation studies , photo stability & temperature cycling .

3) Design Experiments and to deliver the results , demonstrating awareness of customer demands and focus

4) Analytical method verifications with cleaning validation as per the regulatory Guidelines

5) Compliance for various inspections and audits .

• Implementation of c’GMP & GLP Quality systems .
• Preparation of specs for RM/INTER/FINISH for API
• Implementation of quality norms as per regulatory guidelines
• Analytical method Development of R & D Product by spectroscopic Techniques Like HPLC / GC / TLC
• Stability studies :- protocol design , data trending , forced degradation studies .
• Technology Transfer as per regulatory Guidelines.
• Preventive Maintenance & trouble shooting of analytical instruments & Ensure proper maintenance & upkeep of Analytical instruments
• Daily ADL planning : Contribution in Daily ADL planning to ensure adequate support to all R & D Projects, perform analysis & taking responsibility of individual projects & to prepare project completion report .
• Preparation & Release of Final COA as per regulatory guidelines .
• Responsible to approve /reject raw materials , packing materials , intermediates .
• Responsible for investigation of OOS .

• Supporting the quality assurance team for Change control/deviations/incidents/market complaints Involved in quality management review by OOS & OOT Associated for the effective implementation of CAPA .
• Tech transfer of analytical methods to quality control .
• Analytical Method Optimization & preparation of Analytical Method Development Report
• Conducted stressed & long term stability studies

• Spectroscopic analysis of various synthetic molecules, while using separation techniques such as Chromatography (HPLC/GC/TLC) method development, method validation & in process monitoring of different projects
• Troubleshooting & problems solving approach to process and development. Planning and control of operational activities in compliance with c’GMP norms and their implementation.
• Analytical support for drug development and material characterization, responsible for characterization of drugs & materials using various analytical techniques .
• Interact closely with other scientists & engineers and be an integral part of multidisciplinary team that provides support for product & process development as well as manufacturing & Quality Control .

1. Method development of new drugs by HPLC /GC/TLC and total analytical support to process research by qualitative and quantitative analysis.

2. Successful demonstration of developed methods including technology transfer data to quality control lab.

3. Preparation of stability study protocol of various projects

4. Better framework and suitability of work to maintain daily notebook writing and to check all documentation.

Planning and control of various process, validation and maintenance of laboratory instruments and generation of relevant data for quality norms , products and support to synthesis labs