Manager Quality Assurance

QUALITY ASSURANCE MANAGER

VANDANA SANIKOP

SKILLS

SELF MOTIVATED

DECISION MAKER

LEADERSHIP

PERSONNEL MANAGEMENT

QUALITY ASSURANCE MANAGER AT EMPREE

MEDICAMENT(I ) PVT LTD,BELGAUM FEB 2017-CURRENT

• IN CHARGE OF OVERALL QA DEPARTMENT

WORK EXPERIENCE

EDUCATION

RAJIV GANDHI UNIVERSITY

BACHELOR IN PHARMACY

2007 - 2010

BANGALORE UNIVERSITY

DIPLOMA IN PHARMACY

2004 - 2006

PG DIPLOMA IN

REGULATORY AFFAIRS AND

DRUG DESIGNING

2009-2010

CONTACT

MOBILE:955-***-****

HOME:083********

**********@*****.**

• PARTICIPATED IN NSS CAMP ORGANIZED BY RC COLLEGE OF PHARMACY.

PARTICIPATED IN NATIONAL LEVEL PHARMACY TALENT SEARCH EXAM. MEMBER OF PHARMAHELPLINE SOCIETY, JAIPUR.

ACHIEVEMENTS

SUPERVISE ALL QA STAFF PROVIDING LEARNING AND DEVELOPMENT WHERE APPROPRIATE.

REPONSIBLE FOR TIMELY AND ACCURATE IN PROCESS REVIEW OF BATCH RECORDS AND QA CHECKS WITHIN THE MANUFACTURING PROCESS. PROVIDES REVIEW/APPROVAL OF DEVIATION, INVESTIGATION,CAPA, CHANGE CONTROL AND ANNUAL PRODUCT QUALITY REVIEW.

PROMPTLY COMMUNICATES WITH OPERATIONS REGARDING

COMPLAINTS, PRODUCT ISSUES/VARIANCE.

REVIEW AND GIVE APPROVAL OF VALIDATION AND QUALIFICATION PROTOCOLS AND REPORTS AND PARTICIPATE IN VALIDATION ACTIVITY. REVIEW AND GIVE APPROVAL OF CONTROLLED DOCUMENTS SUCH AS PROTOCOLS, MASTER BATCH RECORDS, SPECIFICATION AND SOP’S. INDEPENDENT REVIEW OF EXECUTED BATCH RECORDS, CLEANING VERIFICATION DATA AND PRODUCT RELEASE DATA

PARTICIPATE IN AUDITS ( INTERNAL/EXTERNAL)AS WELL AS REGULATORY AUDITS.

PROFILE

SENIOR QUALITY ASSURANCE OFFICER AT FDC LIMITED, GOA FROM JAN 2011 - AUG-2015

• TEAM LEAD FOR VALIDATION, QUALIFICATION ACTIVITY AND IPQA TEAM.

ADDRESS

SHIVBASAV NAGAR,

BELGAUM,

KARNATAKA QUALITY ASSURANCE OFFICER AT CIPLA LIMITED, GOA FROM JAN 2007 - SEP 2007

•WORKED AS A DOCUMENT CONTROLLER

ASSISTANT QUALITY ASSURANCE MANAGER AT CIPLA

LTD, GOA AUG 2015 - JAN 2017

• TEAM LEAD FOR QUALITY MANAGEMENT SYSTEM.

PERSONAL DETAILS

D.O.B: 10.04.1985

NATIONALITY:INDIAN

MARITAL STATUS: MARRIED

LANGUAGE KNOWN:

ENGLISH, HINDI, MARATHI

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