Manager Quality

Tanuja Bhatt

***** ******** ******* *********, ***** Carolina 28262

704-***-**** Cell *******@***.***

* U.S. Citizen *

Well-respected individual with distinguished 26-years career, leading operations within pharmaceutical laboratory environments. Repeated success guiding sizeable, cross-functional teams in technical and analytical inspection and analysis of diverse raw materials, components and finished products. Excellent written and verbal communication skills. Able to forge solid relationships, present complex and detailed analytical findings and build consensus across multiple organizational levels.

Core technical competencies include:

Phase/Light Microscope

Fluorescence Polarization (Abbott TDX)

Autoclave

Thinlayer Chromatography

Centrifuge, Karl Fisher

LIMS System

Avid Zone Reader

Air Ideal 3P Air Sampler

TOC Analyzer

Spectrophotometer

PH meter

Urinometer

Gas Chromatography

Biolog ID System

MIDI and HPLC Systems

Vitek ID System, HPLC, UV-VIS

Professional Experience & Key Career Accomplishments

QC LABORATORY MANAGER, Nov 2018 - present

Guerbet USA - Raleigh, NC

Primary responsibilities include leading, mentoring and developing the chemistry and microbiology laboratory team

which supports cGMP sterile parenteral manufacturing facility. Provides overall direction, activities and functions as

the authority and expert on chemistry and microbiology strategy, procedures and techniques and regulatory

compliance. Performs administrative duties associated with managing a department and staff (i.e. establishes group

goals, and reviews). Identifies quality issues, and in conjunction with site Quality Manager, recommends and

implements corrective and preventative actions. Supports goals and initiative tied to Guerbet Quality Plan and

department goals. Works with manufacturing and laboratory staff in managing investigation, deviation, CAPAs and

other.

MICROBIOLOGY SUPERVISOR, 2011 – Sep 2018

Ei LLC - Kannapolis, NC & PQ LLC, Daytona, FL plants

SENI

Performs various activities related to the inspection and testing of raw materials and finished products to ensure compliance with established specifications, procedures, policies, and regulatory requirements.

Tests raw materials, finished and stability samples by Microbial Limits, USP <61> <62>,USP<70> and Antimicrobial Effectiveness Test method, USP <51>. Performs Growth Promotion and Biological Indicator (BI) testing on regular basis. Performs Suitability testing to develop the method for new products which includes writing of protocols, execution and final report. Testing and analysis of water and Environmental monitoring data, identification of microorganisms from water, environment and finish products. Performs testing of cleaning validation samples. Review and audit documentation to ensure accuracy, specification and cGMP/cGLP compliance, certified as a Qualified Data Reviewer. Participates in vendor audit on a regular basis, creating investigations for out of specification results and deviations. Coordinates sample handling and Method development in micro department. Trains and provides expertise to subordinate in the lab as per their job requirements. Tracks and trends EM data for preparation of monthly reports. Write and review SOP/STPs when required. Performed training for Micro lab and production personnel for Aseptic methods to avoid contamination in the products. Ensures and maintains calibration, validation of all lab instruments.

Played critical role in all FDA, European Pharmacopoeia, Therapeutic Goods Administration (TGA) and Customer Audits and Inspections.

Investigated major OOS (Out-of-Specification) and CAPA (Corrective Action and Preventive Action) for failing results.

Reviewed and audited documentation to ensure accuracy, specifications and cGMP compliance.

Coordinated and supported validation, engineering and production assignment according to manufacturing schedule without compromising quality.

Coordinated with sustainable Stability Program in compliance with ICH Guidelines for all QC samples.

Oversees sampling and laboratory testing execution to produce results in timely manner without compromising any quality.

Leads the Micro team and retain talented individuals within the QC Microbiology Department.

Schedule and/or delivers training to QC Microbiology personnel in accordance with Department Training Plan to ensure staff can perform assigned tasks correctly, safely and compliantly.

Reviews SOPs, coordinate method development and ensures concurrency with cGMP regulations and requirements.

Utilizes process knowledge, technical knowledge and investigation skills to identify and rectify departmental issues.

Performs Internal and External audit for microbiology lab for our customers.

Prepares budget for micro department, tracking annual expenditure and giving cost of each testing for micro tests.

Saved about 2 million dollars for other facility by testing in-house comapared to outside lab testing.

Selected accomplishments:

Created and implemented Environmental Monitoring Program for building 5 by Air Ideal 3P Air Sampler at both facilities.

Developed a schedule system for AET testing, testing AET samples from other facilty.

Established a Micro assay lab USP<81> buying new equipments, saving about $100,000 by testing Antibiotic samples in house by following Revenue and Capex Budget.

Releses finished products and Raw material samples on time to achieve monthly goal of a company which is 8-10million .

Involved in external and internal audit for both facilities. Implementation of CAPA and FDA regulations at both facilities..

Trained all micro personnel at Kannapolis and Daytona-FL by implementing correct procedures and cGMP requirements.

Resolve Technical problems in accordance with policies at both locations by writing LIR’S and deviations for micro department.

Review audit observations updates and implement lab procedures for both facilities.

Coordinating with R&D for method development by writing protocols and suitability reports for each customer.

.

SENIOR ANALYST, 2008-2011

McKesson-Concord, NC

Senior Analyst to test controlled and narcotic drugs that company repacks in blister packs. Also performed testing on stability products from 40 different vendors by following different test methods and USP testing criteria. Took part in Method Transfer of products. Validated equipment and machinery cleanliness to ensure strict standards and reduce risks of product contamination. Support QA department for latest changes in USP guidelines and update procedures. Checked the work of other analysts, auditing the methods and keep them updated. Helped new analyst in the lab to train by following FDA and USP guidelines.

Selected accomplishments:

Helped in FDA and DEA (Drug Enforcement Agency) inspections.

Conducted training for all employees on cGMP for blood borne pathogen and PPE.

Helped the team to test all the stability samples at different intervals by using SSII program.

Resolved Technical problems in accordance with policies.

Reviewed, updated and implemented lab procedures with changes in regulation.

SENIOR MICROBIOLOGIST, 2003-2007

LEINER HEALTH PRODUCTS, Fort Mill, SC

Senior Microbiologist to lead Microbiology Laboratory Operations. Tested water, finished products, raw materials and various components using Microbial limits testing. Identified Microorganisms from air and water monitoring procedures. Validated equipment and machinery cleanliness to ensure strict standards and reduce risks of product contamination. Prepared tests for microbial analysis.

Selected accomplishments:

Spearheaded SOP (Standard Operating Procedure) methods.

Assisted multiple departments in preparation and completion of FDA (Food and Drug Administration) regular and ad hoc inspections.

Monitored all laboratory Quality Control processes.

Trained associates and new microbiologists to achieve consistency of methods and highest quality standards within laboratory procedures.

Performed audits and maintained detailed documentation standards of all laboratory log books.

Achieved excellent ratings and consistent passing marks during all mandated inspections.

SENIOR MICROBIOLOGIST, 1992-2000

ALPHARMA USPD INC, Lincolnton, NC

Performed antimicrobial assays including (Neomycin, Polymyxin, Bacitracin, Gentamicin, Nystatin) on multiple products within Microbiology laboratory. Completed Preservative Challenge and Microbial Tests on Stability of all Finished products. Responsible for water testing, environmental monitoring and identification of microorganisms. Managed cost effectiveness through strategic laboratory supply/inventory ordering processes. Assisted Lab Managers in FDA inspections and critical technical laboratory reviews performed by prestigious customers such as J&J and Upjohns.

Selected accomplishments:

Trained 180+ employees and provided subject matter presentations on Personal Hygiene and Contamination (portion of GMP training program).

Initiated negotiations with new vendors/suppliers to gain quality service and optimal pricing on laboratory supplies, resulting in $40K annual savings.

Additional Tenures Include: Medical Technologist ~ Roche Biomedical Lab, Birmingham, AL / Lab Assistant ~ Columbus State University, Columbus, GA / Project Officer (Environmental Lab) ~ World Wildlife Fund (WWF), India

Education & Credentials

Medical Technology (Microbiology, Clinical Chemistry, Hematology)

Columbus State University, Columbus, GA

B.S. Biology, M.S. Biology, M.S. University, Baroda, India

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