Quality Assurance Manager
Resume:
To,
The General Manager,
Respected Sir/Madam,
Subject : - Application for the suitable post in Quality Assurance department in your esteemed organization.
I hereby take this opportunity to introduce myself as Vikas Kailashnath Vishwakarma and I have completed M.Pharm (pharmaceutics) from University of Pune and earlier working as a QA officer in Zydus Cadila Healthcare Ltd. from Dec. 2013 to Sept. 2015 & currently as an Senior executive QA in Cipla ltd. from Sept. 2015 to till date.I have been interest to associate as a part of your esteemed organization. I will be very grateful to you if you consider my candidature for a suitable post in your organization.
I am here with enclosing my Curriculum Vittae for your kind consideration and favour and looking forward for your kind response.
Thanking you
Date: Yours Sincerely,
Place:Goa VikasKailashnathVishwakarma
CURRICULUM VITAE
VIKAS KAILASHNATH VISHWAKARMA
Address: A/P Vilas Nagar, College Road,
Amravati. 444604.
Mobile: 986*******
Email: *********@*****.***
OBJECTIVE
In quest of career enrichment in the domain of Quality assurance of high repute.
PROFESSIONAL CAREER SUMMARY
Communicator with excellent negotiation skills, with good writing and communication skills.
One year nine months of experience in ZYDUS CADILA HEATHCARE LIMITED, Kundaim industrial eastate, Ponda, Goa ; as a QA officer.
One year nine months of experience in CIPLA LTD, Verna industrial eastate,Goa ; as an Senior executive in QA department.
KEY RESPONSIBILITY AREAS
Review of documentation related to manufacturing which includes Validation, Media fill, BMR(Commercial & Media fill), Impact assessment, Monthly Trends of alarms (NVPC, Cold storage, etc..)
To look afterwards over all non-routine validation & documentation related to it, includes, Protocol/Reports/Summary/Trending/Schedulepreparation/Document submission & handling of query related to it.
Handling & involvement in deviations/Investigation/Market complaints/Action plans related to operation activity.
Preparation of sampling plan & creation/Raising of technical information sheet in SAP system for different validations/media fill/other (OOS, hold time, etc) sampling if any.
Allocation of work to the officer for shop floor activities in manufacturing areas & also scheduling their daily/weekly basis round in areas to identify any non-conformance/observations in areas.
Handling of different software’s for day to day activities which includes;
1.SAP.
2.SMART SOLVE.
3.CIPDOC’S.
4.WEBSMART.
5.SCADA SYSTEM.
6.QCMS.
7.BMS.
8.Admin log-inn for on-line particle counters handling via pharmanet pharmaceutical software.
Conduct training related to Operations SOP’S. Also give comment on SOP’S draft copy.
Review of FMECA/Scientific rationale related to Operation activity.
Areas of Exposure:
During past working in Pharma Industry, exposure was in following fields:
Exposure to Ampoule/Vial/Liquid/Lyophilized products. This includes General categories, XCM, Hormones, Anticancer Category formulation in parentral preparation.
Involved in investigation related to OOS, OOAC, OOT, Market complaint, Deviation if any.
Thorough documentation review & escalation of non-conformance related to it & if required necessary actions had been taken which includes deviation/CAPA/data integrity issue /FAR filling.
Handling & monitoring of shopfloor activities.
Active participation in Media fill compilation & review.
Performed media fill failure investigation. Prepared summary investigation & final investigation report for the same with concern with all user departments.
Performed practically Area, Temperature mapping, Tunnel, DHS and Autoclave (Fedegrii) validation. Also in packing Seidenader machine validation (Fully automated optical inspection machine), Optical inspector validation. Participate in filling pump, filling machine (Groninger/ Bosch), Vial washing machine (Groninger/Bosch) validation.
Participated in process & cleaning validation studies. Well aware with the matrix & bracketing, API selection, and concepts in process/cleaning validation which includes MACO value, 100 ppm, Dose criteria etc
Well aware with the regulatory and statutory guidelines
Regulatory, Party & Internal Audits:
Faced successfully two times USFDA audit in Month of September-2016 And second time currently in Month of June – 2017 in Cipla ltd.
Faced Tanzania, Indonesia & other party audits MSD, SANDOZ CANADA, PAR PHARMA, DRL, and FRESINOUS KABI in Cipla ltd.
Faced Internal Audits (CQA & SELF INSPECTION BY SITE QA) & performed self inspection rounds of inter units by Co-Ordination with Production Dept. & Confirmation of its compliance.
Faced successful WHO audit in Zydus Cadila healthcare ltd.
EDUCATIONAL CREDENTIALS
M.PHARMACY with 1st class from University of Pune, in 2013. (62.14%)
B.PHARMACY with 1st class from Amravati University, in 2011.(63.04)
D.PHARMACY with 1st class from MSBTE, in 2008. (74.10%)
SEMINARS ATTENDED:-
First prize in Poster presentation at “University Level”.
Poster presentation at “64th Indian pharmaceutical congress” held at Chennai SRM University on topic “Fast dissolving tablet of Sertaline Hydrochloride Solid dispersion”.
Participate in “63rdIndian pharmaceutical congress” held at Bangalore international exhibition centre, Bengaluru during 16th to 18th December 2011.
Participate in the oral session at “NATIONAL CONFERENCE” on “THE INNOVATVE RESEARCH & DEVELOPMENTS IN PHARMACEUTICAL SCIENCES” in Bharti vidyapeeth University Poona College of pharmacy, Pune.
COMPUTER KNOWLEDGE:-
Basics, Internet, MS-Office., MS-CIT.
Good handling of Excel & Matrix & calculation part over Excel worksheet.
PERSONAL DETAILS
Name : Vikas Kailashnath Vishwakarma.
Date of Birth : 6th March 1988
Gender : Male.
Marital status : Single.
Language known : English, Hindi, Marathi.
Religion : Hindu.
CTC : 391600 Lakhs /annum
Notice period : One Month.
DECLARATION:
I hereby declare that the authenticities of all the statements made in this resume are true and complete to the best of my knowledge and belief.
Date:
Place: Goa (Mr. VKAS K. VISHWAKARMA)
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