ANITA RAO

A*/** Flat **,

Jolly Jeevan CHS, LIC Colony,

Borivali (west),

Mumbai 400 103,

INDIA

Mobile No : 982*******

____________________________________________________________

OBJECTIVE:

To work in a reputed organization offering challenging opportunities wherein I can utilize

my knowledge and skills, with an impetus towards overall career development and

updating of quality in the field of Pathology and Clinical Research.

STRENGTH:

Strong leadership, excellent communication skills, competent, strong team player,

attention to detail, dutiful respect for compliance in all regulated environments, as well as

supervisory skills including hiring, termination, scheduling, training, payroll, and other

administrative tasks. A clear vision to accomplish the company goals. Expertise in

Biochemistry, Quality Assurance, SOP writing and Method Validations and Harmonization.

Computer and Internet literate.

WORK EXPERIENCE:

ORGANISATION: Quintiles Technologies (I) Pvt. Ltd. Since Aug 2009 to Oct2011 as

Assoc. Manager Medical Lab.

RESPONSIBILITY

:

Managed a team of 7 Medical Technologists and supervising of daily activities of

assigned laboratory work through appropriate delegation, technical skills training

and work supervision. Meeting regularly with staff and senior management to

discuss and resolve workload and technical issues.

Counseling, training and coaching laboratory staff. Monitoring work, developing

staff skills and evaluating performance.

Maintaining a unified culture and facilitated collaboration, cooperation, sharing of

information and teamwork within the team.

Maintaining appropriate control and quality assurance procedures and ensure

compliance with safety requirements.

Assisting in implementation of new tests, equipments, Quality control programs and

procedures in the assigned areas as needed.

Taking initiative in the process improvement to increase quality of services,

operational efficiency and improvement of metrics.

Enrolment in various certifications (NGSP,CDC, CAP), accreditations –

documentation, follow ups.

Performing the responsibility of Quality Representative for the region and

responsible for the CAPA for all the quality issues and complaints.

Participating in client audits and inspections and have completed 2 successful CAP

inspections with the complete documentation and the requirements for Safety. Have

handled around 10 client audits in the tenure of 2 years.

Performing reviews of daily QC’s, weekly and monthly LJ’s and taken corrective

action in the appropriate manner. Maintaining statistics for the QC’s, Proficiency

surveys and Laboratory Performance monitors. Actively participated in the review of

the PT surveys and troubleshooting the assays as and when required

Well versed and worked with the various QC softwares: BioRad Unity Realtime and

Randox QC.

Providing training on assay validations, quality control, handling of proficiency

samples, QC software’s etc. Documentation of assay validations, biannual linearity,

method comparison.

Participating in drafting SOPs and reviewing them.

Coordinating with vendors on continuous basis for an effective vendor

management.

Reviewing inventory management.

Effective communication with the Project Management team to resolve queries.

Worked on various instruments: Roche Modular, Siemens Centaur, Siemens

Immulite 2000XPi, Siemens Clinitec, BioRad Variant II, BioRad D10, BioRad PhD

Analyzer, Beckman Coulter HMX, LH750.

Responsible for the documentation, applications and technical write ups required

for the application of licenses for import/ export of samples and waste

management.

ORGANISATION: P .D.Hinduja National Hospital & Medical Research Centre as a

Senior Laboratory Technician since Dec 1997 to July 2009 in the Biochemistry

Department.

RESPONSIBILITY:

Worked as the Quality Coordinator for the Biochemistry Department since 2006.

•

Have gone through CAP (College of American Pathologists) audits since 2006.

Have undergone training for NABH (National Accreditation Board for Hospitals &

Healthcare Providers) as a representative for Biochemistry Department.

Actively involved in Method Validation Studies.

Actively involved in Maintenance Procedures for various Biochemistry Analyzers.

Actively involved in preparing the Quality Manual and the SOP’s for various

procedures.

Have undergone training in operation and maintenance of instruments: Beckman

•

Coulter analyzers (Unicel DXC800, Synchron LX20, Synchron CX 9, Synchron El ise,

Immage –immunochemistry system, Access 2, Spectrophotometer DU800)

Radiometer ABL520 Blood gas analyzer, Vitros DT60, Osmometer, Elecsys 1010,

COBAS e411,Abbott Axsym, Abbott TDx, Abbott IMx .

Have been trained in special tests like Toxic Screen for drugs of abuse, various

•

chemistries like 5HIAA, Catecholamines, VMA, Oxalate, Adenosine Deaminase, Zinc,

Copper by manual procedures, Sweat Conductivity by Wescor Nanoduct.

Have successfully completed Competency Assessment 2008 by CAP in the following

•

topics: 1) Liver Function and Renal tests.

2) Laboratory Waste & Spill Management.

3) General Laboratory Safety.

ORGANISATION: Ganjawalla Laboratory for a period of 3 years till Sep 1997.

RESPONSIBILITY:

Worked in Biochemistry, Hematology, Microbiology, Clinical Pathology

departments.

Also worked on project for Industrial Pollution control for Nirlon group under

Prof.

M.T. Pandya).

EDUCATIONAL QUALIFICATIONS:

YEAR UNIVERSITY QUALIFICATION RESULTS

1995 SIES College, Diploma in Medical 75 %

Mumbai Laboratory First Class

Technology

1994 Wilson College of B Sc (MicroBiology) 57 %

Arts & Science, Second Class

Mumabi

1991 Mithibai College, H.Sc. 63 %

Mumbai First Class

EMINARS/CONFERENCES ATTENDED

S :

2012

Presented a lecture on “WRITING OF STANDARD OPERATING PROCEDURES” at

TATA MEMORIAL HOSPITAL at the All India Medical Technologists Conference held

on 22nd 23rd Dec 2012.

2010

Attended a Inspector training seminar College of American Pathologists

Accreditation Program conducted by the College of American Pathologists in 2010

at HindujaHospital.

2008

Participated in the Seminar on Quality Awareness organized by Quality Council of

India and Biorad Laboratories on 18/09/08. Topics covered: Frequencies of QC,

Lean Six Sigma in Quality Management and Medicolegal aspects for Clinical

Laboratory.

Participated in the 35th ACBICON 2008 National Conference at Kolkata. Presented a

paper on “Use of Nonfasting Triglycerides for CHD risk stratification.”

2007

Attended the 4th Annual QC meet organized by Biorad Laboratories Pvt Ltd and

Quality Council of India on 7th Sep 2007 at Mumbai. Topics covered were

Measurement if Uncertainty, Method Evaluation, QC in Infectious Disease Testing.

Attended a training programme on GCP and GLP held on 23 25th Aug 2007 at

Hinduja Hospital organized by Institute of Clinical Research(India).

2006

Attended a workshop on Quality Awareness organized by the Quality Council of

India and Biorad Laboratories on 16th Feb 2006. Topics covered were Accreditation

for Medical Laboratories ISO15189 and QC concepts.

Attended certificate course in “Good Clinical Laboratory Practices” held on 4 6 Oct

2006, gave an oral presentation on Method Validation on 7th Nov( AMR

Verification) conducted by the Dept.of Biochemistry and Clinical nutrition at Seth

G.S. Medical college and KEM Hospital.

2005

Attended 2nd QC users meet organized by Biorad attended lectures on NABL

accreditation. Lecture by Dr. James Westgrad on Biological variation on 19th Sept

2005.

Attended TOXOCON 1 Inaugral Conference, Indian Society of Toxicology held at

Amrita, Institute of Medical Sciences, Cochin, Kerala, held on 28th Nov 2005.

Participated in poster presentation on “Retrospective analysis for urine drug

screening” and won the best poster award for the same.

TRAININGS ATTENDED AT QUINTILES:

Good Clinical Practice training for 3 consecutive years 2009,2010 and 2011.

Also completed a training in Good Clinical Practices fir Administrative

Support Staff by Barnett Education Services in April 2011.

Good Data Recording .

Fraud and Misconduct .

European Union Clinical Trials Directive.

Incident Management.

Deviations from Established Procedure.

Manage, Lead, Succeed Rules of the road for Managing at Quintiles.

Training on Improving Performance through Coaching.

Personal Effectiveness.

Leading Change.

Advanced User Training for drafting and reviewing SOP’s as per the

accreditation guidelines.

Training for the documentation and performing the Qualification of

Instruments, Equipments and Medical Devices.

Training on ERES : Advanced Principles and FDA Guidelines.

Leading for Performance.

Audit Etiquette Training.

Quality Issue and Complaint Management.

Bloodborne Pathogen and Chemical Safety Training.

Global Privacy Awareness.

ACHIEVEMENTS:

Worked in an environment with a lot of work pressure where time

management, team work, quality and customer satisfaction is a priority. Also, able

to co ordinate and control resources, and personnel effectively and efficiently and

maintain best quality standards. Effectively maintained a globally harmonized

laboratory. Actively involved in the project of lab expansion, maintaining the work

efficacy, turnaround time of the reports and quality at all times.

REFERENCES: Available on Request

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