Sr Executive QA PHARMA Resume
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Resume:
EDUCATIONAL QUALIFICATIONS:
v Masters in Pharmacy (Pharmaceutical Chemistry) - Rajiv Gandhi Proudyogiki Vishwavidyalaya with first class in as a GATE qualified candidate.
v Bachelors of Pharmacy -Barkatullah Vishwavidyalaya with first class in .
INDUSTRIAL EXPERIENCE:
v Presently Working as QA –Sr. Executive Aurobindo pharma Ltd.(Unit_III) Hyderbad from-March-.
v Worked as QA-Executive in Piramal Healthcare Limited, Digwal from Jan- to-Feb -.
AUDIT PREPARATION WORK:
US FDA, MCC, FDA, MHRA.
CUSTOMER AUDIT
Astra zeneca,mylan,Northstar,pifzer
RESPOSIBILITY
v Preparation & review of validation documents i.e. Various Protocols (process validation protocol), reports & in-process control activities Participated in change control, deviation.
v Review of batch records.
v Perform in- process activities.
v Participated in audit work.
v Monitor cGMP in shop floor.
v Carried out calibration of IPQA instruments.
v Monitor shop floor activities.
v Prepare IPQA SOP’s as per current system.
v Review batch documents, calibration reports, STP.
v Preparation & review of validation cleaning validation protocol and report.
v Customer complaints record and support in investigation
v Monitoring and performing sampling activities.
v Participate in market complaint investigation.
v QA- Documentation as per the Regulatory norms
v Annual Product Quality Review
v Periodic execution of mock recalls(Dummy product Recall)
v Master batch / manufacturing records preparation and their updates to Regulatory departments.
v Overall coordination for the implementation and management of Quality Management systems.
v Customer complaints record and support in investigation
v Responsible for coordinating day to day activities of preparing, issuing, reviewing, maintaining, archiving and destruction of various Quality documents and maintaining the QA record room.
v Responsible to cater to the needs of external customers with reference to questionnaires and other technical document requirements such as pre audit questionnaires.
v Manufacturing site artwork and Packaging material approval and documentation activity.
v Investigate the cause of any non conformance and its corrective / preventive action
v Operational knowledge as per Good Manufacturing Practices (GMP) requirement
v Coordinate with all the departments concerned, such as Marketing, Production and Quality Control Departments with respect to the products manufacturing.
INDUSTRIAL CERTIFICATE
v Productivity improvement Anaesthetic plant ().
v Certificate of Appreciation in ‘Manthan’ operation for successful project done Feb-.
v AICTE, Scholarship for post graduation as GATE qualified candidate.
SOFTWARE SKILLS:
MS-WORD, MS-EXCEL, POWER-POINT, CORAL DRAW, CHEM DRAW, NOTPAD.
PERSONAL PROFILE:
Name : SHASHANK KHARPATE
Father Name : SHRI. SHARAD KHARPATE.
Citizenship : Indian
Location preferences : India
Passport :G(Valid upto //)
Marital Status : Married.
Date of Birth : Feb
REFERENCES:
- Available on request.
DECLARATION
I hereby declare that the above furnished details are correct and true to the best of my knowledge and belief.
SHASHANK KHARPATE
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