1. ATUL BORSE
Mobile: +91-9890680446 E-Mail:
incredibleatul87@gmail.com
Qualification: M.sc. in Analytical Chemistry Total Exp.: 4.4 Years
CAREER OBJECTIVE :
Assignments in Quality Control and Quality Assurance with an organization of high repute.
CAREER CONSPECTUS
A dynamic professional with over 4.4 years of rich experience in Quality control and Quality
Assurance departments.
Proficient in handling market complaints and accountable for quality service & timely completion
of the quality related assignments.
Hands on experience in HPLC, Dissolution Tester, GC, FTIR, Karl Fisher, UV Spectrophotometer.
Maintains the GMP & GLP activities & follows WHO & Schedule L standards.
An effective communicator with excellent relationship management skills and strong analytical,
leadership, decision making, problem solving & organizational abilities.
SCHOLASTICS:
M.sc (Analytical Chemistry) from M. J. College, Jalgaon with First class in year 2011.
B.sc (Chemistry) from Z.B. Patil College, Dhule with Second class in year 2008.
CAREER SKETCH:
Current employer:
Johnson & Johnson Ltd. Aurangabad Since May 2014 till date
As Executive- QA
The Accountabilities:
Handling Market Complaints.
• Registering the complaints received from the market into Siebel (Complaint management
software)
• Acknowledgement of received complaints.
• Conducting DHR review for the complaint
• Conducting Retain/Complaint sample analysis.
• Follow up with the sales representatives and doctors for complaint samples and additional
information.
• Closure of complaints and sharing of the closures with the sales representatives and doctors.
• Filing of the complaints and related documents.
Document management (Issuance and Retrieval) as per SOP.
BMR, Run sheets and Analytical data review.
Stability Study Chambers Handling and Maintenance.
Preparation of Stability Study trend, Schedule and validation and Calibration protocols.
Previous employer:
Wockhardt LTD. Biotech Park –EOU Tablet
H-14/2, MIDC Area, Waliuj, Aurangabad-431136
Since October 2013 To May 2014 as Jr. Executive
The Accountabilities:
Analysis of finished products and stability study samples.
Calibration of various analytical instruments.
Troubleshoot various problems related to instruments during analysis.
1
2. Preparation of SOP’s, STP’s & Developing protocols as per regulatory requirements.
Support in Regular lab audits & Internal Audit Management to ensure quality compliance of the product
as per the GLP guidelines.
Assist in US-FDA, UK-MHRA, ISO, BSI, X change & internal Audits.
Compliance to Audit Recommendations arising out of Audits.
Implementation and Compliance to Quality Management Systems at site.
Ensuring compliance to cGMP, 21 CFR part 11, Group Quality Policies and Guidelines at site.
Hands on Instruments:
• HPLC (High Performance Liquid Chromatography)[Make- Waters, Schimadzu, Dionex and
Agilent (Softwares –Empower-3, EZ-chrome, Class VP and Chromeleon)]
• FTIR (Fourier Transforms Infrared Spectrophotometer)(Make-Perkin Elmer)
• Karl Fisher Titrator (Make-Metrohm)
• UV & VIS Spectrophotometer (Make-Schimadzu)
• Dissolution Apparatus (Electrolab, Varian)
• Disintegration test Apparatus
• GC (Gas Chromatography) (Make-Schimadzu)
Previous employer:
Ajanta Pharmaceuticals. LTD.
Chikalthana, Aurangabad (M.S.) 431210
Since November 2012 To October 2013 As Officer- QC
The Accountabilities:
Sampling & analysis of raw materials & finished products.
Preparation of SOP’s, STP, OOS, Process Specifications, Developing protocols as per regulatory
requirements.
Control and Revision of Documents.
Regular lab audits & Internal Audit Management to ensure quality compliance of the product as per the
GLP guidelines.
Assist in ISO Audit, BSI Audit, X change Audit & internal Audits.
Compliance to Audit Recommendations arising out of Audits: Regulatory, Corporate group and Internal.
Implementation and Compliance to Quality Management Systems at site.
Ensuring ISO 13485-2003, ISO 9000 compliance in the plant & Verification of action plans for Non
Compliances.
Ensuring compliance to cGMP, Group Quality Policies and Guidelines at site.
Troubleshoot various problems related to instruments during analysis.
Previous employer:
Johnson & Johnson Ltd. Aurangabad. Since April 2011 to Oct 2012 As Officer- QC
The Accountabilities:
Sampling & instrumental analysis of raw materials & finished products.
Responsible for monitoring & preparation of Change Controls, OOS incident and Deviations in time.
Preparation of SOP’s, STP, OOS, Process Specifications, Developing protocols or operating instructions as
per the regulatory requirements.
Ensures that all equipments are calibrated.
Control and Revision of Documents.
Regular lab audits & Internal Audit Management to ensure quality compliance of the product as per the
GLP guidelines.
Assist in ISO Audit, BSI Audit, X change Audit & internal Audits.
Compliance to Audit Recommendations arising out of Audits: Regulatory, Corporate group and Internal.
Implementation and Compliance to Quality Management Systems at site.
Ensuring ISO 13485-2003, ISO 9000 compliance in the plant & Verification of action plans for Non
Compliances.
2
3. Ensuring compliance to cGMP, Group Quality Policies and Guidelines at site.
Ensures that products are developed, manufactured, tested and stored so that quality is maintained.
Attended trainings on:
ISO 13485:2003 Medical Devices Quality Management Systems Introduction Course conducted by BSI.
5 s & Kizen management.
Good Documentation Practices (GDP) as well as Good Laboratory Practices (GLP) training.
Research Project:
An industrial project -
“Determination of active ingredient in commercial formulation of insecticides”
• Project sponsored by BIOSNTHETICS a bio-fertilizer company.
• Qualitative & quantitative determination of active ingredient (Imidacloprid) from commercial
formulation of insecticide using High Performance Liquid Chromatography (HPLC) & Fourier
Transform Infrared Spectroscopy (FTIR).
Achievements:
•• Winner of twoWinner of two Zonal Chess tournaments.Zonal Chess tournaments.
•• Qualified two timesQualified two times National Chess Tournaments.National Chess Tournaments.
•• Participated inParticipated in TV showsTV shows and college level singing competitions.and college level singing competitions.
•• Participated inParticipated in one day workshopone day workshop onon ISO 13485:2003ISO 13485:2003 held atheld at Johnson and Johnson LtdJohnson and Johnson Ltd..
AurangabadAurangabad
Computer Knowledge:
LIMS
Minitab
MS OFFICE
SAP
Personal dossier:
Name : Atul Chhagan Borse.
Father’s Name : Chhagan Appa Borse.
Present Address : C/O M.D Kulkarni
Kalyani Apartment, Flat no. 4,
Shambhu Mahadev Nagar,
Aurangabad-431001
Permanent Address : 26, Shantiniketan housing society,
Walwadi T&D Dhule-424002
Date of Birth : May 16th
1987.
Gender : Male
Nationality : Indian
Marital Status : Married
Language Known : Marathi, English, Hindi.
Declaration
I do hear by declare that the above information is true as per my knowledge and I bear the responsibility for
the correctness of the above mention particulars.
Date:
3