Quality Assurance Pvt Ltd

Name: TamilselviManickam, PhD in Life Sciences

Email: *******************@*****.***, *******@*****.**,

Phone No.91-(0-995*******

Present address: No.35 VIIth Phase, Bhaskara Aparments, Near Vijaya Avenue

MG Nagar, First Extension, Annai Anjugam Nagar, Urapakkam West

Pin 603211, Chennai, India.

Sex: Female, Married

PRESENT WORK EXPERIENCE

2004 to Present- Eight ears work experience as a clinical research scientist in Clinical research organization in Chennai, India.

1. Responsibilities:

Establishing and maintaining Quality management system

2. Document control

3. Monitoring and assuring of all Laboratory activities

4. Review the quality manual as per the requirement

5. Schedule and conduct of internal audit

6. Schedule and conduct of Management Review Meeting

7. Review and closure of corrective and preventive action

8. Provide review for identified NC.

9. Provide training in order to support for quality assurance activities and ensure consistency across test procedures.

10. Site initiation and facility audit

11. Training of offsite and in house personnel

12. Monitoring offsite trials.

13. Ensuring GCP/ICH compliant preparation and execution of clinical trials

Scientific processing of adverse event reports according to internal SOPs. Monitor study progress such as patient recruitment and protocol compliance.

14. Study data listings and tables review, including scientific content and data validation.

13. Writing reports, SOPs

14. Train internal and external study personnel in study specific procedures GCP, GLP and ISO 15189,17025

15. Managing entire team of clinical

16. Assuring Quality of Bioanalytical and clinical datas

WORK EXPERIENCE

Sep 2004- Worked as a Postdoctoral fellow INRA (National Research Institute), Dijon, France.

2002- 2003-Worked as a postdoctoral fellow at INRA (National Research Institute), Dijon, France.

2000-Worked as Research Associate for a short term research project at Kobe Women's University in Dept of Life sciences. Japan.

1999-2000 Worked as Research Associate in Dept of biochemistry, IISC, Bangalore. India.

1999- Worked as a Research Assistant at School of Life Sciences, University of Hyderabad, India.

1998- Worked as a research associate in Molecular Biology Training at Academia Sinica, Taiwan.

EDUCATIONAL QUALIFICATION

2000 PhD in Life Sciences, School of Life Sciences, University of Hyderabad, India.

1992 M.Phil in Plant Sciences (Biochemistry), Bharathiar University, Coimbatore,

COMPUTER SKILLS

2002- Completed PG Diploma in Bioinformatics., SISI, Chennai, India.

2001-2002 Completed Software Diploma. (Unix and C), Radiant Software Limited, Chennai and CSC Computer Education, Chennai, India.

2002-Proficiency in French Language

PUBLICATIONS

Four publications in the International journals in the field of Life Sciences.

TECHNICAL SKILLS

Clinical research Oncology trial, Vaccine trial, Cell biology, Molecular biology, Biochemistry, Proteomics, Signal transduction and Biotechnology.

HONOURS & AWARDS

2000-Awarded Research Associate from CSIR, New Delhi, India.

1999- Received Depts. Science and Technology Senior Research fellowship, New Delhi, India.

1992-1998-Received University grants commission Junior and Senior Research fellowship, New Delhi, India.

1990-Awarded Graduate Aptitude Test of Engineering (GATE)

Received Award of Skills and Efficiency in Plant Sciences, Silver Medal,

Life time membership in Society for Plant Physiology and Plant Biotechnology, New Delhi, India.

WORKSHOPS

Attended and presented regional, national and international conferences in the field of Life sciences.

Attended many GCP, GLP, regulatory compliances and ethics conferences, workshops and , seminar.

And faced FDA, ANVISA, DGCI, MHRA, TGA, BFAC, NABL and MCC audits and several sponsor audit

References

1. Sujatha Chandrasekaran,M.D,

Senior Consultant, Cl.Microbiology & Serology,

Global Hospitals & Health City,

439,Cheran Nagar, Perumbakkam,

Chennai 600100.India

2.Dr. Arivazhagan, MBBS, MD

Physician

Quest Life Sciences Pvt Ltd,

SDF III

MEPZ, Tambaram, Chennai 600045, India

3.. Dr. Anand Babu

Physician

Quest Life Sciences Pvt Ltd,

SDF III

MEPZ, Tambaram, Chennai 600045, India 91(0)956-***-****

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