Process Manager

Falguni Khokhal

* *********** *****

EDISON, NJ *8820

Cell :732-***-****

********@*****.*** Home :732-***-****

SUMMARY:

Results oriented Reagent Supervisor in cGMP environment in Medical device

industry for formulation process for Reagents used in medical diagnosis

(coagulation/ Hemostasis management and POC testing for critical

care).Over 8 years of experience leading/ managing production of reagent

products, implementing process improvements, troubleshooting product

quality issues to achieve and exceed targeted goals. Oversees and plan

Reagent formulation/ production and manages inventory in a manner that

ensures efficient quality production and timely delivery of existing and

new/ modified products. Responsible to execute weekly Reagent formulation/

production plan in compliance with FDA, GMP and ISO-9001

standards.Responsible to write/ revise Standard Operating Procedures

(SOPs) ensuring that they are current and in compliance to meet company

and cGMP guidance. Strong expertise to execute process/ equipment

validation (IQ/OQ/PQ) and summarize results, prepare reports. Identify

weekly company priority to Staff current along with daily routine

activities and review current workload and previous week's operation and

results. Excellent team player, self-motivated, well organized and has the

capability to work independently with strong decision-making skills.

Knowledge of reviewing in-process test results/ reports, data generated

during formulation/ production and analytical test data generated in Lab.

Knowledge of writing technical reports for investigation/ root cause for

non-conforming materials. Proficient to operate document management

software Trackwise

WORK EXPERIENCE:

ITC, Edison, New Jersey

Supervisor, Reagents

(March 2007- Present)

. Responsible to oversees, prepare and execute weekly Reagent production

plan in compliance with all established specification and control

procedures.

. Responsible to keep accurate training records, plan and direct training

sessions to improve efficiency of technical staff.

. Identify areas to improve department activities through additional

training, updating Standard Operating Procedures (SOPs) and forms to

keep them current to ensure all documentation reflects the state of

compliance and control required by the QA and RA.

. Direct special projects independently and provide quality planning to

ensure compliance.

. Attend functional meetings to coordinate action to resolve technical

problems relating to raw materials and finished products.

. Provide concise and organized recommendations for corrective action

when necessary.

. Responsible to provide investigation reports including root cause and

corrective actions and manufacturing assessment for non-conforming

materials/ deviations/ OOSs.

. Responsible to revise Standard Operating Procedures (SOPs) under

engineering change control as required per the outcome of investigation

root cause.

. Responsible for coordinating associated investigation reports for CAPA

in a timely manners.

. Responsible to execute process/ product/ equipment IQ/OQ/PQ validation

protocols, document results, prepare and publish reports.

. Responsible to maintain in-process testing data base and perform

relevant statistical analysis including trend analysis.

. Responsible for auditing, reviewing and approving data generated in

formulation lab for in-process testing and instrument calibration/

verification for accuracy and cGMP compliance.

. Responsible to schedule characterization of new in-coming raw materials

in a timely manner to allow timely delivery of existing products.

Falguni Khokhal

2 Hearthstone Drive

EDISON, NJ 08820

Cell :732-***-****

********@*****.*** Home :732-***-****

. Responsible for procuring maintaining laboratory inventory for

consumables, chemicals, Ref standards, instrumentation

parts/accessories.

. Provide support and guidance to direct reports and address any issues

and report to Department Manager and Director on completion of

activities of self, staff and any open issues.

. Coordinate with vendors and suppliers on different technical and non-

technical issues related to products and laboratory requirements.

. Responsible to maintain and ensure that the calibration and PM schedule

for the equipments/ instruments are up to date and in compliance.

ITC Edison, New Jersey

Assistant Supervisor, Reagents

(January 2004 - February 2007)

. Reviewed and Audited data for Reagent formulation lab for in-process

test for accuracy and cGMP Compliance.

. Supervised and trained employees for Standard Operating Procedures

(SOPs) used for formulations and in-process testing and

Spectrophotometers, Fibrometers, Stago ST art 4 instruments used for

testing.

. Responsible to prepare weekly schedule for Reagent formulation lab and

characterization of new lot of raw materials to allow timely delivery

of products.

. Responsible to maintain laboratory inventory for raw materials used for

formulation, reagent used for in-process testing and reference

standards etc.

. Responsible for providing Investigation reports for the closure of non-

conforming materials, handling deviations and OOSs.

. Responsible to execute Process/ Product/ Equipment validations and

report results.

. Assisted in writing/ updating SOPs to reflect current practice and

ensure compliances.

. Worked with R&D, QC and QA; attended core functional meetings to

coordinate action to resolve technical problems relating to

formulations and raw materials.

. Responsible to generate monthly reports for the outcome of validation

process execution.

. Responsible to ensure that the calibration schedules for the

equipments/ instruments are up to date and in compliance.

. Proficient to operate Lyophilizers used for the lyophilization of

Reagents and trained other employees to operate Lyophilizers.

. Responsible to address any issues and report to Depart Manager

completion of activities of self, staff and any open issues.

ITC Edison, New Jersey

Reagent formulation technician

(July 2000 - December 2003)

. Conducted formulation process, performed in-process QC testing on for

Reagents during formulation process using coagulation instruments to

detect clotting times APTT, PT and TT.

. Responsible to perform testing for characterization of raw materials

efficiently.

. Trained other employees for formulations and in-process testing.

. Responsible for operating and monitoring Lyophilizers.

. Utilized Fibrometers, Spectrophotometers and other coagulation time

detecting instruments for in-process daily test activities.

. Performed testing for range generation for Reagent used for in-process

testing.

Falguni Khokhal

2 Hearthstone Drive

EDISON, NJ 08820

Cell :732-***-****

********@*****.*** Home :732-***-****

EDUCATION:

> Bachelor of Science, Major in Microbiology

> Saurashtra University, India, April 1993

CERTIFICATIONS:

> Medical Laboratory Assistant Certificate, National Healthcareer

Association- Jan. 2000

> Phlebotomy Technician Certificate, National Healthcareer Association-

Jan. 2000

COMPUTER SKILLS:

> Proficient in Microsoft Word, Excel and Power Point

> Trackwise

> ORACLE JD Edwards Enterpriseone software

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