Microsoft Office (Word, Excel & PowerPoin)
Gaurav Katore
Master Of Pharmacy (Pharmaceutics)
Mumbai,Maharashtra
Summary
Senior quality assurance officer with 5 years of work experience in both parenteral as well as solid oral manufacturing organizations.
PROFILE SUMMARY: Meticulous Quality Assurance Officer with a keen eye for detail when it comes to developing managing and performing various quality assurance activities. Committed to ensuring that all established quality standards are followed. Specialize in evaluating the quality of manufactured products and the processes with which such products are created.
CORE QUALIFICATIONS: Excellent ability to gather and analyze data to evaluate quality. Extensive understanding of problem resolution techniques and processes. Strong ability to prepare quality assurance reports. Impressive organizational and planning skills ability to meet strict deadlines while retaining quality standards. Good written and verbal communication abilities.Ability to maintain confidentiality as necessary.
Overview
5
5
years of professional experience
9
9
years of post-secondary education
1
1
Language
Work History
Senior Quality Assurance Officer
IPCA LABORATORIES Ltd
Athal, Silvassa
08.2021 - Current
- Provided recommendations on ways to improve or update existingQA standards
- Handled response related to queries received from the customer and regulatory department
- Assigned no. to CCP, Deviation & CAPA
- Hands on review of deviation,CCP & CAPA in trackwise software
- Reviewed investigation reports & root/probable cause
- Hands on preparation & review of site SOP'S, master document (BMR, BPR & MFR) in absence of concerned person
- Well versed in preparation of most types of QA documents
- Trained new members of the quality assurance team and provided mentoring
- Reported identified critical compliance risks to senior management.
- Investigated reports & justifications of quality issues with various products
- Hands on review of executed BMR as well BPR
- Prepared COM, TSCA, TSE/BSE as per customer requirement
- Review of retention sample log & periodic observation of retention sample.
- Any other job which associated by Quality Assurance Head
Senior Quality Assurance Officer
UMEDICA LABORATORIES Pvt. Ltd
Vapi, Gujrat
03.2021 - 08.2021
- Hands on review of BMR & BPR
- Actively listened to customers, handled concerns quickly and escalated major issues to supervisor.
Senior Quality Assurance Officer (Shift incharge)
INTAS PHARMACEUTICALS LTD
Ahmedabad, Gujrat)
03.2017 - 03.2019
- Ensured the compliance of Current Good Manufacturing Practices in General Parenteral manufacturing area as well as Packing area
- Ensured the equipment used are within the due course of qualification status
- Performed In-process control checks during manufacturing as well as packaging operations
- Gave line clearances for manufacturing as well as packing operations
- Performed sampling of retained samples, QP Sample stability study samples and other regulatory sample during the packing operation
- Performed various SAP transactions
- Raised vendor complaint for material with discrepancy & fill vendor complaint form with preliminary investigation & forwarded to CQA for further action
- Ensured online documentation and its integrity in processXE software
Quality Assurance Officer
SAMRUDH PHARMACEUTICALS Pvt. Ltd
Boisar, Mumbai
09.2017 - 02.2019
- Reviewed the executed batch manufacturing & packing records for regulatory as well as ROW market
- Performed line clearance activities during batch to batch change over and product to product change over in both manufacturing & packing area
- Familiar with process validation & packing validation
- Performed inprocess checks & sampling
- Familiar with media fill activity execution & review of media fill documents
- Carried out destruction of expired raw material, packing material, finished & semi-finished goods as per standard procedure
- Reviewed environmental monitoring reports
- Ensured proof check during startup of the packing activities
- Ensured documentation and its integrity
- Reviewed daily calibration record, stereo issuance and destruction record, equipment and area cleaning logbooks.
Education
Master of Pharmacy - Pharmaceutics
University of Pune
Pune 03.2015 - 03.2017
Bachelor of Pharmacy -
Shivaji University
Kolhapur 03.2011 - 03.2015
H.S.C. - Science
Viva College of Science
Mumbai 03.2009 - 03.2011
S.S.C. -
Vartak Vidyamandir
Mumbai 06.2008 - 06.2009
Skills
Current Good Manufacturing Practices (cGMP)
Software
SAP (System application & product)
ProcessXE (eBMR & eBPR)
SCM (Supply chain management)
Trackwise (QMS)
EDMS (Electronic data management system)
Additional Information
- Got achievement in calender year 2009 as a member of japan karate association
- Played role as a senpai ( upperclassman who mentors an underclassman i.e. kohai)
Accomplishments
- Developed ability to ensure compliance with company standards and improve efficiency.
- Improved manufacturing process according to customer concerns.
Internet Surfing
Having interest to search for new informative sites, which talks about trending pharmaceutical technologies.
Timeline
Senior Quality Assurance Officer
IPCA LABORATORIES Ltd
08.2021 - Current
Senior Quality Assurance Officer
UMEDICA LABORATORIES Pvt. Ltd
03.2021 - 08.2021
Quality Assurance Officer
SAMRUDH PHARMACEUTICALS Pvt. Ltd
09.2017 - 02.2019
Senior Quality Assurance Officer (Shift incharge)
INTAS PHARMACEUTICALS LTD
03.2017 - 03.2019
Master of Pharmacy - Pharmaceutics
University of Pune
03.2015 - 03.2017
Bachelor of Pharmacy -
Shivaji University
03.2011 - 03.2015
H.S.C. - Science
Viva College of Science
03.2009 - 03.2011
S.S.C. -
Vartak Vidyamandir
06.2008 - 06.2009
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