Quality Control Team Member
Resume:
[BINAL PATEL]
Portsmouth, NH - 03801]
[*****************@*****.***]
A Trained and qualified Microbiologist having 8+ years of rich and insightful experience of reputed sterile injectables facilities in Quality Control microbiology department. Skills
• [Handling of GLP section]
• [Employee development]
• [Method validation for sterility, MLT]
• [Maintain healthy environment at all-time]
• [Always believe in team work]
• [Sterility assurance]
Work Experience
[May 2018] – [Jan 2021]
[Executive QC] [Amneal Pharmaceuticals Private Limited, Ahmadabad - India]
Take care of IQ, OQ, PQ for new instrument.
Take care of all qualification and requalification activity.
Area qualification of microbiology lab and production area.
Preparation of study protocol and execution.
Preparation of KRA for new joinee and old team member.
Perform internal audit in cross functional department as well other facility of Amneal group.
Handling of all kind of procurement of laboratory and make cost effective for organization.
Handling of all activity regarding GLP (Good Laboratory Practice).
Preparation of standard operating procedure.
Sterility testing and its validation.
Bioburden analysis.
Preparation of Water sampling schedule and collect samples of WFI, Pure steam, purified water for microbiological testing.
Perform Environment monitoring, & Preparation of trend.
Take care of complete training of new joinee.
[Apr-2017] – [Apr-2018]
[Executive QC] [Emcure Pharmaceuticals, Ahmadabad- India]
Handling of water system validation including testing.
Temperature monitoring study of incubators and media store room.
Preparation of standard operating procedure.
Documentation review.
Document issuance and control.
Validation document compilation and review
[Feb-2015] – [Mar-2017]
[Executive QC] [Intas Pharmaceutical Limited (Biopharma Division), Ahmadabad]
Perform Environment monitoring, & Preparation of trend.
Perform Routine calibration activity as per prescheduled calendar.
Sterility testing and its validation.
Bacterial Endotoxin test.
Bioburden analysis.
Culture maintenance and disposal activity, Handling of BI.
Media preparation for routine microbiological activity & GPT.
Preparation of Water sampling schedule and collect samples of WFI, Pure steam, purified water for microbiological testing.
Exposure to establishment of new microbiology laboratory.
[May-2014] – [Oct-2014]
[QC Microbiologist] [Claris Lifescience, Ahmadabad - India]
Sterility testing and its validation.
Documentation review.
[Sep-2011] – [Apr-2014]
[QC Microbiologist] / [Swiss Parenteral Pvt Ltd, Ahmadabad - India]
Sterility testing and its validation.
Bacterial Endotoxin test.
Bioburden analysis.
Perform Environment monitoring, & Preparation of trend
Culture maintenance and disposal activity.
Media preparation for routine microbiological activity & GPT.
LPC Test (Liquid particle count)
Preparation of standard operating procedure.
Audit compliance report preparation
Documentation review.
Document issuance and control.
[Sep-2010] – [Aug-2011]
[Tr. Chemist] / [Nirlife, Ahmadabad - India]
Sterility testing
Water Analysis
Education
[MARCH-2010]
[M.Sc. IN BIOTECHNOLOGY] / [Ganpat University, Kherva]
[MARCH-2008]
[B.Sc. IN BIOTECHNOLOGY] / [North Gujarat university, Patan] Activities
In Amneal Pharma face USFDA audit and give 100 % contribution in my organization and we clear all audit without zero observation.
In Intas Pharma (Biopharma division) face Health Canada audit and perform bioburden analysis in front of auditor.
Contact this candidate