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Clinical Research, Microbiology, Clinical QA/ QC, regulatory affairs

Location:
Bengaluru, Karnataka, India
Posted:
February 21, 2018

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Resume:

Bangalore, Karnataka, India

ac4j38@r.postjobfree.com

+918*********,946-***-****

1) Quality Assurance and Quality Control (QA & QC).

2) Clinical Research.

3) ICH GCP, ICMR Guideline. Drug and Cosmetic Act-Schedule Y, USFDA.

4) GMP & WHO Guideline, Drug and Cosmetic Act-Schedule M.

5) Documentation like IQ, OQ, PQ with easy archival / retrieval.

6) Validation, SOPs & Protocols as per WHO and GMP.

7) Auditing, Clinical Quality Auditing (CQA), Regulatory Affairs.

8) CRC.

I

Proficient with window 98/xp, Window 7, Window 8, Microsoft Office 2015.

Participated in National Table Tennis (TT) Championship in Vadodara (Gujarat).

Participated in National Integration Camp Conducted by Youth Service and Sports (J&K).

Successfully completed final sem. Project title “Expression and Purification of Mycobacterium Tuberculosis Proteins” from Institute of Genomics and Integrative Biology (IGIB) CSIR, New Delhi.

Attend Workshop on Compensation Issues in Clinical Trials Industry Harmonization and Solutions.

NIKHAL BANOTRA

SUMMARY

A proactive and result oriented Life sciences Professional with over 3.5 years experience in Pharmaceutical industry and CROs.

Having worked with QA and Clinical research exposure to Vaccine manufacturing industry. Well versed with global and local regulatory bodies.

Equipped with a strategic mind-set that facilitates the formulation and implementation of strategies that have significantly helped organisations to bring in operational and process efficiency leading to better bottom lines.

Exemplary interpersonal, leadership, communication, and presentation skills

Demonstrates high Perseverance & Integrity and believes in leading by example

Education

1.Post Graduate Advance Diploma in Clinical Research & Pharmacovigilance (PGADCR & PV) from Institute of Clinical Research India Delhi (ICRI) 2014 -2015.

2.MSc Microbiology from Doon PG Paramedical College and Hospital Dehradun, H.N.B Garhwal University, UK in 2011.

3.BSc (CBZ) from Govt Degree College Poonch, Jammu University (J&K) in 2008.

4.12th from GBHSS Poonch, JK Board in 2005.

5.10th from GBHSS Poonch, JK Board in 2003.

Work History

Fortis escorts Heart Institute & Research Center Delhi as Clinical Research Coordinator (CRC) from 2015 to 2016.

Clinical research knowledge, clinical research fundamentals.

ICH GCP, ICMR Guideline. Drug and cosmetic Act – Schedule Y, USFDA.

Role and responsibilities of Key Stakeholders.

Assist in Recruiting subject, screening including Informed consent process (ICF), randomization, enrollment and follow up (including telephonic Follow up) process & procedure.

CRF, e-CRF entry, Data Query resolution.

Maintaining study files. Submitting regulatory documents to IEC and Sponsor. Submitting the clinical study agreement. Prepare Trackers in Excel.

Overview of Pharmacovigilance, regulatory aspects in Pharmacovigilance.

Clinical Data Management.

Bio-Med Pvt. Ltd (Vaccine Manufacturing Company) Ghaziabad as a QA Executive from 2012 to 2014.

Maintain complete documents of various departments Polio vaccine, Polysaccharide vaccine, Bacterial Toxin division & Rabies Division.

GMP & WHO Guideline. Drug and cosmetic Act – Schedule M.

Validation of autoclave, DHS, LAF, Biosafety cabinet, Dynamic Pass Box.

Implementation and formation of SOPs & Protocols as per WHO & GMP & also maintained documents like Obsolete files, Training records, General document, Preventive maintenance.

Maintain Documentation like Installation Qualification, Operational Qualification, Performance Qualification- (IQ,OQ,PQ ) with easy archival/retrieval.

Maintain general documents, preparation of new documents & assignments for the department.

Calibration of Weighing Balance, Deep Freezer & Incubator.

Practical knowledge of HVAC & its validation.

Environmental microbial monitoring.

Maintaining Master Validation Plan.

Assistance in managing internal & external audits like WHO & NRA Audit.

Microbiological Examination of Water.

Total Microbial Count. Microbial Limit Test for WFI Purified Water.



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