Pharmacy Technician trainee
Resume:
RESUME
AMRUT NATVARLAL DARJI
**************@*****.***
Mobile No. +1-409-***-****
SUMMARY OF PROFESSIONAL EXPERIANCE
Having an industrial (formulation –OSD & Injectable ) experience of more than 25 year in the area of Quality Control with various Pharmaceutical organizations like Zydus Cadila, Sun Pharma, Intas, Sakar Healthcare Formulation Plant.
I have Faced the Audit of Regulatory Agency like EUGMP, UK-MHRA, USFDA, FMHACA- ETHIOPIA, MCAZ- ZIMBABWE, NDA- UGANDA, FDA – PHILIPPINES, FDA-GHANA, WHO GMP, NAFDAC-NIGERIA & other activity like GLP, Stability, QMS part - Incident, OOS /OOT Handling, Training, Deviation, Change control, Market complaint, Vendor Qualification. I am working in Present Organization –Jambuwala Pharmaceuticals Ltd at Ahemdabad from April’2023 to till this date as a Consultant for Quality (QC-GLP /QA /QMS /Documentation work) Previously worked in Stallion laboratories Pvt Ltd (OSD Formulation –Unit-1 at Kerala GIDC, Bavla,Ahmedabad ) from March’2021 to March’2023 as a AGM-QC(Operation Head) Sakar Healthcare Ltd ( EU Approved – Formulation Plant like OSD, Parenteral ( Lyo & SVP at Changodar, Ahmedabad) from 15th April 2019 to Nov’2020 as a AGM-Quality (QC & QMS). Details of my work experience is given below.
WORK EXPERIENCE :
STALLION LABORATORIS PVT LTD ( FROM –March’2021 to March’2023) –AGM-QC Operation Head
SAKAR HEALTHCARE LTD- AHMEDABAD- (1.5Year ) - AGM – QC & QMS.
UNIMARK REMEDIES LIMITED. AHMEDABAD (CARBAPENEM FACILITY) -( Work Experience: 4 Year) - Sr. MANAGER –QC-HEAD (CARBAPENEM)
INTAS PHARMACEUTICALS LTD. AHMEDABAD -( Work Experience: 7 Year ) - ASST.MANAGER –ONCO QC (STABILITY SECTION HEAD)
SUN PHARMACEUTICALS INDUSTRIES LTD. –HALOLPLANT, VADODARA -( Work Experience: 2 Year ) -Sr. EXECUTIVE (Reviewer in QA in QC )
ZYDUS CADILA HEALTHCARE LTD, MORIYA PLANT, AHMEDABAD -( Work Experience: 10 Year) - Executive –QC
LINCOLN PHARMACEUTICALS LTD, AHMEDABAD -(Work Experience: 4 Year ) - Sr. QC Chemist.
QC ACTIVITY :
Actively participates in Site Quality committees and works with multi-functional Quality team, Planning, Manufacturing, Process validation and others as required to resolve technical issues, satisfy quality and production needs.
Ensure that all product quality complaints from the market are investigated promptly within stipulated time frame, develop & implement strategies to address any identified adverse trends.
Leads, develops, implements and maintains quality strategies, procedures and systems in line with corporate business goals.
Ensures that these quality strategies, procedures and systems provide assurance that the quality of Products, processes and procedures are in compliance with all applicable regulations and continually improve Quality systems and implement corrective actions as appropriate.
Safety Policies to ensure departmental compliance with company requirements and minimize accidents & hazards.
Quality Metrics Management Responsible for the improvement in compliance-focused Quality Metrics.
Trending of Metrics (inclusive of Quality Investigations, Lab Incident, Out of Specifications, Out of calibrations, Out of Trends and Corrective and Preventive Actions) on monthly basis and analyze them on quarterly and annually.
Responsible to notify / escalate to Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Internal Audits: Quality Operations inclusive Manufacturing, Packaging, Facilities & Engineering, Material Management and Quality Control.
External Audits: Contract testing laboratories and RM / PM vendors.
Co-operate with QA for final approval in Quality Management system such as Change Management,
Vendor Management, Market Complaint, Incidents, OOS / OOT, Investigations and CAPAs.
To ensure the establishment of a robust talent management program within the Quality systems, Compliance groups and ensures supervisory staff develops the technical, business process and leadership skills.
Review and approve AMC / CMC, contract laboratory Confidentiality Disclosure Agreements, Quality Agreements, Change Controls and Investigations.
Identify and lead initiatives in support of continuing improvement in Quality and Customer Service both internally and externally.
Lead risk assessment initiatives related to Quality operations.
Conduct performance reviews of reporting managers and staff. Actively involved in the recruitment process.
TECHNICAL COMPETENCIES:
Knowledge of regulatory requirements related to pharmaceutical manufacturing and 21 CFR requirements.
Understanding of policies, guidelines and systems related to quality assurance programs, cGLP and cGMP audits
Hands on experience with various Analytical Instruments. Assist with the identification of alternative test methods and /or equipment to improve efficiency and maximize throughput of testing in the laboratories.
Involved in the selection, configuration and qualification (i.e. IQ/OQ/PQ) of instruments with multiple specialized software systems.
Technical writing and review (includes AMT protocols, Test Methods, Standard Operating Procedures, Quality Agreements, Confidentiality Disclosure Agreements, Change Controls, Deviations, Investigations, CAPAs, responses to Regulatory Agency observations, etc.) AWARDS AND ACHIEVEMENTS :
Received double increments and Promotion in the hard work for First USFDA Facility Audit at April 2004 and also successful of Analytical side for project of new product Launch Pantoprazole Lyophilize Injection.
SOPHOSTICATED INSTRUMENT OPERATED LIKE :
HPLC, GC, FTIR, UV/VIS SPECTROPHOTOMETER, DISSOLUTION, AAS/ ICP-OES & MS), KF Titrator, Potentiometric Titrator
SEMINAR ATTENDED :
Thermo fisher Instrument of ICP-OES & MS for Elemental impurities analysis as per USP-2018 (effective from Jan-2018) seminar at Hotel courtyard Marriott, Ahmedabad, India
Metrohm new instrument of IC & ICP seminar at Hotel Novatel, Ahmedabad, India.
Agilent- cross lab seminar at Hotel Fern and Hotel Novatel –Ahmedabad, India.
Thermo fisher instrument HPLC and method validation & development seminar attended at Hotel Hyatt at Ahmedabad. India.
EDUCATIONAL QUALIFICATION:
1989 : Bachelors of Science with Chemistry subject, Gujarat University-AHMEDABD, GUJARAT, INDIA
PERSONAL DETAILS :
Date of Birth : 06-Oct-1969
Gender : Male
Marital Status : Married
Salary Expected: Based on my Experience & as per company rules
Residential Address: 6040 N Major Dr
Apt 1406,
Beaumont,
Texas-77713
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