1. RESUME
KAVITA SHARMAKAVITA SHARMA
OBJECTIVE:
Seeking for challenging assignment, in the field of quality assurance, in pharmaceutical organization. I
would like to be a part of quality assurance team of the organization that has the potential of recognition as
well as augmentation of my skills.
EDUCATIONAL QUALIFICATION:
Degree College/Institute University/Board %
B. Pharmacy Rayat Institute of Pharmacy, Ropar PTU 76.00
D. Pharmacy
Govt. Polytechnic women’s college,
(Solan)
HP Takniki shiksha Board 70.00
SSC Govt. Girls Sen. Sec. School, (Solan) HP Board Dharamshala 58.00
AUDITS FACED:
Regulatory Audit USFDA- United States Food and Drug Administration (USA)
MHRA, EU- GMP, ANVISA.
Local Audit Local FDA Audit, WHO,
Customers Audit like FDC, Dr.Reddy, Apotex
WORK EXPERIENCE:
Total: 8.4 Years.
Company Name: Akorn India Private Limited
Duration April 2016 onwards
Designation Sr. Executive-QA Training
Company Name: Sentiss Pharma (Formerly known as PROMED EXPORTS) (An EU GMP
certified company)
Duration July 2008-Mar 2016.
Designation Sr. Executive-Production
Reporting to Manager Production till 2013 and Manager QA (2013-MAR2016)
Approval Approved chemist in manufacturing (Ophthalmic)
Company Name: MDC Pharmaceuticals (Solan)
Designation Officer QA
Duration 2005 - 2006.
Reporting to AGM- QA
RESPONSIBILITIES:
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Rishi Apartments
Block C-1, Room No. 101, Baddi (HP)
Email- 1984ons@gmail.com
Mobile No.: 9816584531/9418079406
2. TRAINING MANAGEMENT:
cGMP training monitoring.
To impart training on cGMP, GDP & Data integrity.
Awareness training on regulatory guidelines and market complaints.
Training need identification
Identification of trainees for. SOP’s.
EXPOSURE OF:
QUALITY MANAGEMENT SYSTEM:
Change Control, CAPA, Deviation and Incidents.
OOS, OOT Investigation.
Internal audit.
MANAGEMENT OF IPQA TEAM AND IPQA ACTIVITY:
Management of IPQA team members in three different lines.
Planning and coordination with cross functional team.
Management of IPQA activity in manufacturing, filling and packing section.
Ensure on line documentation.
Responsible for quality decision at shop floor.
Ensure online in process checks.
Reviewing final batch documents and trends before batch releases.
Supportive role in facility & equipment validation.
Collection of samples (In Process, Reserve & Stability sample for QC department).
DOCUMENTATION:
Document issuance & retrieval.
Batch record and SOP preparation.
Document review.
Batch Release.
KNOWLEDGE OF:
• Batch Manufacturing and Filtration.
• Autoclave operation (Pharmalab).
• CIP & SIP of manufacturing tank.
• System ERP for inventory of Consumables.
• CIP & SIP Validation.
• Autoclave Validation.
• Filter integrity.
COMPUTER PROFICIENCY:
MS Word, MS Excel, Power point presentation
PERSONAL DETAILS:
Father's Name : Mr. R.K Sharma
Permanent Address : Village-Kalaghat. P.O-Oachghat, Solan
Date of Birth : 17FFEB1984
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