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Clinical Research: QC, Pharmacy

Location:
Pune, Maharashtra, India
Salary:
8.0 Lakhs
Posted:
April 29, 2019

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Resume:

Curriculum vitae

M I". Sandeep Surshing Chandanshe

Contact No. +91-997******** 866-***-****

E-Mail: sande~ac880h@r.postjobfree.com

OBJECTIVE:

Seeking for further challenges where my knowledge and experience could be utilized for mutual benefit of the organization and for myself. I want to build my career in a progressive organization that will provide me with a good opportunity to grow personally and professionally.

!ACADEMIC PROFILE:

• Passed M. Pharmacy with First Class in Year 2010, from NMIMS College, Shirpur, NMIMS University.

• Passed B. Pharmacy with First Class in Year 2008, from Yash Institute of Pharmacy, Dr. Babasaheb Ambedkar Marathwada University.

• Passed D. Pharmacy with First Class in Year 2003, from Channabasweshwar D. Pharmacy College, Latur, MSBTE.

• Passed H.S.C. with Second Class in Year 2001, Maharashtra State Board.

• Passed S.S.c. with First Class in Year 1999, Maharashtra State Board.

• MS Office (Word, Excel & PowerPoint), Internet.

CURRENT JOB:

Working as Research Scientist in Wockhardt Ltd (CPB dept.) from 19 th

April 2010.

Job Responsibilities:

1. Quality Control

• Quality check of the documents like Informed consent forms, Case report forms, SDTM domains, Clinical study report and all the data generated during clinical phase of the BA/BE studies as per protocol & regulatory requirements & submission within timelines.

• Write and revise SOPs for clinical section as per need & maintain awareness of all current SOPs.

• Visit to the CROI Hospital to monitor the Bioequivalence studiesl trial sites.

• Calibration and maintenance of clinical equipment's (centrifuge, deep freezer, food weighing balance).

2. Pharmacy

• Responsible for executing pharmacy related activities such as Receiving Investigational products along with relevant documents for verification.

• Responsible for Dispensing & maintaining accountability of Investigational products.

• Clinical Research Co-ordinator for clinical trial sites. Gender : Male

Marital Status: Married

J,cA--.l-

~:p Surshing Chandanshe

: Indian

: Ist September 1984

3. Sound knowledge ofICH GCP and BA/BE regulatory guidelines. 4. Successfully faced Regulatory audits of US FDA (3), UK MHRA (2), DCGI (6). KEY SKILLS:

I. Sound knowledge of Clinical Standard Operating Procedures. 2. All Essential regulatory Documentation for Bioequivalence and Bioavailability. Curriculum vittle

• Responsible for Archiving/ shipment ofInvestigational products at the end of the clinical phase & Disposal of Investigational products after retention period .

• To ensure calibration status & responsible for maintenance of pharmacy including all the equipments and to ensure the Eurotherm Records. 3. Training Coordinator

• Responsible for arranging and coordinating the training schedule for all new recruits and existing staff in consultation with Head clinical.

• Responsible for SOP training and On the Job training to all new recruits and contractual staff.

4. Project Related Activities

• Project related activities such as ICF Process, Dosing, Dosing supervision, Blood sample processing and separation, Clinical Custodian duties, subject check in and check out activities etc.

Nationality

Date of Birth

Languages Known : Marathi, Hindi and English

Present Address : N-7, J CIDCO, PLOT No. 84, Kalapandit Housing society, Aurangabad 43 1001

Permanent Address : At Gandheli, Post. Adgaon, Ta. Dist. Aurangabad PERSONAL INFORMATION:

I hereby solemnly, do affirm that the particulars furnished above are true to the best of my knowledge.

Date: 25 f o ~ ( 19

Place: Aurangabad

IRELEVANT EXPERIENCE:

1. Major Project (M. Pharm. Pharmacology): Bioavailability Study of an Anticholinergic Drug on Adult, Healthy Human Subjects under Fasting & Fed Condition completed in Wockhardt CPB Dept., Mumbai. 2. Worked as a Pharmacist in 'Rajlaxmi Medical' at 'Mahendrakar Hospital', Aurangabad for about one & half year.



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