Quality Control A V
Resume:
CURRICULAM VITAE
Pawan Kumar Patel
**, ******* ******** ****** ***
Dist. Indore (MP) – 453331 India
M. No.:079********, 997127949
E-Mail: ********@*****.***
STREAM: “Chemical Science”
CAREER OBJECTIVE: A challenging position with growth opportunities. MY STRENGTH:
I am confident determined open minded in discussion, planning in time, translating plan in to reality, positive attitude, continuously update myself with latest issue of my profession.
ACADEMIC QUALIFICATION:
S. No.
Course
Board/University
Year
1.
M. Sc. (Chemistry)
Analytical Chemistry &
Medicinal Chemistry
D.A.V.V. Indore
2007
2.
B. Sc. (Micro-Biology)
D.A.V.V. Indore
2004
3.
Higher Secondary
M.P. Board Bhopal
1999
4.
High School
M.P. Board Bhopal
1997
WORK EXPERIENCE (16 Year):
Working with Golden Drug Limited subsidiary of BAL Pharma Udaipur as Manager Quality Control since October-2024 to till date.
Worked with Unichem Lab. Ltd. Pithampur (WHOISO 9001, USFDA, EU GMP Approved) since Jan 2014 to October-2024 as Asst. Manager Quality Control.
Worked with Plethico Pharmaceuticals Ltd. Kalaria Indore (WHO,ISO 9001, MHRA Approved TGA Australia) from Oct 2009 to Jan 2014 as Sr. Officer Quality Control.
Worked with Unichem Lab. Ltd. Pithampur (WHO,ISO, USFDA Approved) from Oct 2007 to Oct 2009 as officer Quality Control.
INSTRUMENTS HANDELLED: HPLC: Waters with EMPOWER-3 Software Agilent 1200, 1250 Series, GC HEADSPACE
(Perkin Elmer) with 500 and 580 model, GC
Schimadzu-2014, UV, IR, Polarimeter (Jasco)
Karl Fischer Apparatus (Metrohm), Malvern
Particle Szier-3000, Analytical Balance and other
General instruments.
TECHNICAL SKILLS:
Quality Control Manager - Golden Drug Limited subsidiary of BAL Pharma Udaipur since October -2024 to till date.
Handling of QC team, responsible for LIMS activity, audit trial review and utilization of laboratory instruments.
Daily analysis planning and co-ordination with manufacturing team for releases and approval activities.
Analytical data review and approval activities by using LIMS software.
QMS activities- Deviation, OOS, OOT Non-Conformance, laboratory Incident investigations.
Handling of Customer audit and regulatory audits.
Trouble shooting of QC Instruments like HPLC, GC, UV, IR, Karlfischer apparatus and other laboratory instruments.
OOS/Deviation/OOT Trend analysis.
Handling of Regulatory and submission queries.
Working Standard and Reference standard Management.
Preparation and harmonization of SOP with current CQA guidelines and as per regulatory compliances.
Periodic audit trail review of laboratory instrument software's of HPLC, GC, UV, IR, karlfischer apparatus, Polarimeter.
Team, Manpower & Resources Management.
QC Asst. Manager –Unichem Laboratories Limited Pithampur Indore, Jan 2014 to October- 2024.
Handling of QC team, responsible for LIMS activity, audit trial review and utilization of laboratory instruments.
Knowledge on QC Analytical instrument (HPLC, GC, Malvern Particle Sizer-3000 model, UV, FTIR, Melting point, pH meter Polarimeter, karlfischer apparatus
Qualification/ Calibration of analytical instruments.
QMS activities- Deviation, CAPA, OOS, OOT Non-Conformance, laboratory Incident investigations.
Daily analysis planning and coordination with manufacturing team for releases and approval activities.
Analytical Method development/Analytical Method transfer/Method validation/Method verification on Malvern Particle Sizer-3000
Handling of customer market complaints/queries.
Implementing cost saving projects in QC.
Handling of Customer audit and regulatory audits- USFDA/EUGMP
Implementing 21CFR / Data integrity / GLPs Norms in lab.
Team, Manpower & Resources Management.
Trouble shooting of QC Instruments like HPLC & GC and other laboratory instruments.
OOS/Deviation/OOT Trend analysis.
Handling of Regulatory and submission queries.
Working Standard and Reference standard Management.
Preparation and harmonization of SOP with current CQA guidelines and as per regulatory compliances.
Periodic audit trail review of laboratory instrument software's of HPLC, GC, UV, IR, karlfischer apparatus, Polarimeter, Malvern Paricle Mastersizer. QC Sr. Officer – Plethico Pharmaceuticals Ltd. Kalaria Indore, Oct 2009 to Jan 2014.
Handling and maintaining, work allotment for the work flow of 5 team members as per the requirement.
Handling and Closing the laboratory Investigation with proper CAPA.
Preparation and revision of SOPs,STPs, requirements
Preparation of the monthly work status report to the manager.
Report checking and reviewing for all analysis on regular basis.
Co-ordination for the regulatory audits, customer audits with the manager.
Analyzing and preparation the reports for the regulatory queries samples and customer samples as per USP/BP/EP on time.
Routine checking and intending for chemicals, stationaries, columns, spare parts on requirement.
Reviewing of Technology transfer documents and verifying the current needs for new projects.
Method development of Herbal products by HPLC.
Preparation and Standardization of Volumetric Solutions.
Sampling of Raw materials, packing Materials, Intermediate and Finished products.
Raw materials analyses of samples, chemicals and packing materials.
Working Standard and Reference standard Management.
Calibration of analytical instruments.
QC Officer –Unichem Laboratories Limited Pithampur Indore, Jan 2007 to Oct 2009.
Analyzing solvents, chromatographic purity and other impurity using GC.
Handling of HPLC for the analysis of API finished products, in-process and intermediate samples.
Preparation and Standardization of Volumetric Solutions, Sampling of Raw materials, packing Materials, Solvents and API, analysis of Raw material samples, chemicals and packing materials.
Preparation and maintenance of documentation (Specifications, certificate of analysis, reports and results).
AUDIT FACED:
WHO with Unichem Labs. Ltd. Pithampur in Year 2007.
USFDA with Unichem Labs. Ltd. Pithampur in Year 2009.
UKMHRA with Plethico Pharmaceuticals ltd Indore in year 2010.
TGA Austraia with Plethico Pharmaceuticals ltd Indore In year 2010.
USFDA with Unichem Labs. Ltd. Pithampur in 2016, 2018 & 2019. COMPUTER SKILLS:
Empower, Chem Station (Agilent) and LC Solutions.
Good Computer Skills.
LIMS.
SAP Handling.
PASSPORT DETAILS:
PASSPORT NUMBER : U1361471
DATE OF ISSUE : 28/11/2019
DATE OF EXPIRY : 27/11/2029
PLACE OF ISSUE : Bhopal (MP India)
PERSONAL INFORMATION:
Fathers Name : Shri Bhuwaniram Patel
Mothers Name : Late. Smt. Durga Devi Patel
Date of Birth : 20 March 1982
Address : 69 Shri Krishna Paradise colony Rau (Indore Marital Status : Married
Nationality : Indian
Religion : Hindu
Hobby : Singing & Listening Music and Playing Cricket Languages Known : Hindi & English
Current CTC. : 14.5 Lacs per annum
Expected CTC : Negotiable.
Hereby I declare that all the information’s given above are correct and true to my knowledge and belief.
THANK YOU,
Place: Indore
Yours sincerely: Pawan Kumar Patel
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