Manager Quality
Resume:
RESUME
Title :
M.Sc. [Organic Chemistry] with 15+ years of pharmaceutical experience in Quality Control Department and Stability Study Department.
Address:
Plot No. 28, “Dhananjay”, Swatantra Sainik Colony, Nageshwarwadi, Aurangabad – 431001
************@*****.***
*************@*****.***
PRITAM GULABRAO DEKATE
Objective
:
To work in a challenging position where my education and accomplishment will contribute to success of the organization.
Education
:
S.S.C.
:
Passed in the year of March 1996 from NAGPUR DIVISIONAL BOARD in Second Division securing 57.86 %
H.S.S.C.
:
Passed in the year of March 1998 from NAGPUR DIVISIONAL BOARD in Second Division securing 52.00 %
B.Sc.
:
Passed in the year of March 2001 from DR. BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY in First Division securing 74.35 % with the subjects “CHEMISTRY, BOTANY AND ANALYTICAL CHEMISTRY”.
M.Sc.
:
Passed in the year of October 2003 from DR. BABASAHEB AMBEDKAR MARATHWADA UNIVERSITY in Second Division securing 54.33 % with subject “ORGANIC CHEMISTRY.”
Computer Skill
:
Passed the “Certificate course in Computer Operation” held in July 1997 in First Division.
Personal Information
:
Nationality
:
Indian
Place of Birth
:
Hinganghat, Dist. Wardha (Maharashtra State)
Date of Birth
:
April 25th, 1981
Languages
:
Marathi, Hindi, English
Job Experience :
Present
:
Working as an “Deputy Manager” at “Mylan Laboratories Limited”, Ahmedabad from 16/01/2018 to till date.
Department
:
Quality Control
Job Profile
:
Investigation of laboratory incidents, OOS and OOT.
Provide internal training for QMS functions including organizational training and subject matter expertise for QMS compliance and process improvements
Facilitates management of QMS resources and objectives, including: Regulatory Compliance, Internal Audits, Corrective and Preventive Actions (CAPA), QMS Metrics and Records.
Preparation of “Trend Assessment” report with respect to the laboratory discrepancies.
Monitoring of implementation of recommended CAPA with respect to the laboratory discrepancies with its effectiveness check.
Ensuring timely compliance of any investigation with verifying CAPA activities.
Supporting quality related customer complaint investigations.
Preparing quality standard documents for smooth running of projects (Technical write up of investigation report).
Providing support and advice during cross-functional investigations/projects and as required.
Review of an analytical document.
Following good laboratory practices and safety in laboratory.
Rendering direct support during customer and regulatory audits.
Working as a bridge between top management, middle management and up to shop floor/benchtop activities for discussion of compliance issue with solution.
Having sound exposure of facing various regulatory audit faced like US-FDA, MHRA, TGA, MCC, ANVISA, WHO.
Previous
:
Worked as an “Assistant Manager” at “Glenmark Pharmaceuticals Limited”, Aurangabad from 16/01/2017 to 23/08/2017.
Department
:
Quality Control Department – Stability Section
Job Profile
:
To plan and ensure timely analysis of stability samples within the time period as per SOP.
Ensure good laboratory practices in the laboratory, adherence to the safety.
Complete management of internal and external calibration of laboratory instruments as well as equipment’s.
Complete management of annual maintenance of laboratory instruments as well as equipment’s.
Review of analytical data for its accuracy and reliability.
Ensure the timely investigation and completion of laboratory incidents.
To review OOS, OOT and Deviation along with full scale investigation.
Preparation and review of SOP’s, Stability protocols and reports.
Qualification of new instruments and equipment’s in the laboratory.
Communication with the other departments / sections for the execution of inter-departments / sectional activities.
To review OOS, OOT and Deviation along with full scale investigation.
To conduct training programmes for staff to increase the knowledge and skills.
To identify area for improving quality of work and suggest cost reduction.
Previous
:
Worked as an “Assistant Manager” at “Torrent Pharmaceuticals Limited”, Ahmedabad from 24/02/2014 to 07/01/2017.
Department
:
Quality Control Department – Analytical Stability Laboratory and
Analytical Quality Assurance
Job Profile
:
To plan and organize section activities on day-to-day basis for timely analysis and release.
To check and verify all the test reports and related documents and ensure the compliance of SOP and GLP in the laboratory.
To supervise calibration and validation of certain equipment’s used in the department.
To enforce and implement SOP’s, cGMP, cGLP and Safety & Housekeeping in consultation with QC Manager / AGM and GM (QC).
To prepare shift rotation for chemists and implement the same.
To conduct training programmes for staff to increase the knowledge and skills.
To carry out daily planning of HPLC analysis to ensure the timely release of stability products.
To identify area for improving quality of work and suggest cost reduction.
To evaluate and discuss performance appraisal of sub-ordinate staff with QC Manager / AGM and GM (QC).
To review OOS, OOT and Deviation along with full scale investigation.
To ensure that the Quality, Health, Safety, Environmental and Energy policy and procedures are followed.
Review and Approval of analytical reports through SAP.
Review and approval of stability summary sheet of stability study products like tablets and capsules.
Internal and external audit preparation and execution.
Review and approval of stability study protocols.
Regulatory audit faced like US-FDA, MHRA, TGA, MCC, ANVISA, WHO.
Aware with the ICH guidelines.
Previous
:
Worked as an “Executive” at “Wockhardt Limited”, Aurangabad from 14/12/2009 up to 18/01/2014.
Department
:
Quality Control - Stability Study Department
Job Profile
:
Review of stability analytical reports and compilation sheets of stability product like Tablets, Capsules, Injections, Ophthalmic and oral suspensions.
Submission of the stability data to Regulatory Affairs department for US and Europe filings.
Conducting In-house training programs for SOPs, Operation and Troubleshooting of instruments.
Preparation of SOPs for Analytical instruments.
Preparation of calibration schedule for all the instruments used in the laboratory.
Communicate with Outsourced Agency’s for performing calibration of instruments in the laboratory.
Analysis of different types of formulation for US and Europe products and Rest of the World samples.
Data back-up and storage of critical instruments.
Training to the newly join analyst for handling of instruments like UV –VIS Spectrophotometer, pH Meter, HPLC system Agilent with Chem station software, Waters with Empower software, Karl Fischer, Dissolution Tester and Auto-titrator.
Calibration of HPLC – Waters, Agilent, Dissolution Tester, UV-VIS Spectrophotometer, Analytical balance, Karl fisher and auto titrator.
Instruments Handled
:
HPLC [Waters, Agilent and Shimadzu]
UV-VIS Spectrophotometer [Shimadzu – 1700]
Karl Fischer and Auto-titrator [Mettler]
Dissolution test apparatus [Varian]
Previous
:
Worked at “Concept Pharmaceuticals Limited”, Aurangabad from 24/04/2004 up to 16/04/2008 as a “Quality Control Officer”.
Department
:
Quality Control Department
Job Profile
:
Working as a Team leader for Bulk Drugs Analytical Cell.
Method Development for the Newly formulated products.
Reaction monitoring for the bulk drugs (R&D) on HPLC.
Analysis of Raw material and the formulated finished products.
Analysis of Raw materials and Finished products of the API.
Packing material analysis and their regarded documentation.
Preparation of Standard Operating Procedures.
Preparation of Working Standards with their related documentation work.
Preparation of Method of analysis, Specification and Purchase specification for the raw materials and finished products.
Preparation of Marketing samples as per the customers requirement.
To fulfill the requirement of Outside party’s Questionnaire.
Preparation of DMF for the API products.
Training to the newly join Chemist about Chemical and instrumental analysis.
Instruments Handled
:
HPLC [ Agilent, Jasco and Shimadzu ]
Gas Chromatography [Netel Chromatograph (Ultima-2100 Series)]
FT-IR [Shimadzu]
UV-VIS Spectrophotometer [Shimadzu-1700, Shimadzu-160A]
Polarimeter [Perkin Elmer]
Karl Fischer Apparatus [Spectralab and Veego]
Potentiometer [Spectralab]
Dissolution Test Apparatus [Veego]
Previous
:
Promoted as “Sr. Executive-QC/ARD” at “Concept Pharmaceuticals Limited”, Aurangabad from 28/04/2008 up to 13/12/2009
Department
:
Quality Control Department and Analytical Research and Development Department.
Job Profile
:
Worked as a Team leader for Formulation, Bulk Drugs Analytical Cell and Analytical Research development team.
Monitoring the quality control activities for the smooth functioning of work as per cGMP and cGLP guideline.
Method Development for the newly formulated products.
Method Validations, Process Validation and its documentation work.
Preparation of Method of analysis and Specification for the Newly developed products.
Monitoring of Quality control activities such as Raw material, Blend samples, Finished products analysis and stability samples.
Preparation of Certificate of analysis for the dispatched materials.
Preparation of Standard Operating Procedures.
Analysis of Stability samples of formulation sample.
Training to the newly join Chemist about Chemical and instrumental analysis.
Instruments Handled
:
HPLC [Agilent, Jasco and Shimadzu]
Gas Chromatography [Netel Chromatograph (Ultima-2100 Series)]
FT-IR [Shimadzu]
UV-VIS Spectrophotometer [Shimadzu-1700, Shimadzu-160A]
Polarimeter [Perkin Elmer]
Karl Fischer Apparatus [Spectralab and Veego]
Potentiometer [Spectralab]
Dissolution Test Apparatus [Veego]
Additional Qualification
:
Having FDA approval from the Govt. of Maharashtra in “Chemical and Instrumentation Testing”.
Having FDA approval from the Govt. of Maharashtra in “Microbiology and Sterility Testing”.
Having FDA approval from the Govt. of Maharashtra in “Pyrogen and Toxicity Testing”.
Passed the “Elementary Grade Drawing Examination”
(Govt. of Maharashtra) in the year of 1994.
Passed the “Rashtrabhasha Kovid” examination.
Notice period
:
03 Months
Strength
:
An optimistic, hardworking, fast learner with ability to deal with people diplomatically, and a team facilitator.
Signature
:
[ Pritam Gulabrao Dekate]
Date
:
Contact this candidate