www.clintechresearch.com CLINTECH RESEARCH India Pvt Ltd : ClinTech Research

[muthukalee]

QA/QC Manager

Responsibilities :
* The preparation of the companies QA manual consistent with the company's policy together with national and international standards.
* Preparation, control and the distribution of all the companies' quality documentation and amendments and revisions including procedures and manuals in accordance with regulations and customer's specifications.
* Monitor all quality related activities on the project and quality audits of the clinical data and investigator sites.
* Review quality inspection, personnel qualifications and training requirements.
* Coordinate all QA/QC activities

Qualification/Requirements :
* Minimum 5 years post-degree experience in Clinical Research with at least 02 years in Clinical Quality Assurance.
* Graduates/PG in life sciences, B.Pharm, M.Pharm M.B.B.S or PhD qualification or equivalent.
* Proficient in use of MS Office (Word, Excel and Access)
* Willingness to travel - regional, national and international including overnight stays.

Experience : 5+ Years

Location : India

If you have relevant experience and would like to be part of ClinTech Research family, please send your resume to career@clintechresearch.com for further consideration.

About us :
ClinTech Research, founded in 2005 in New Jersey, USA, has a team of advisors and consultants with substantial experience that includes technical project management and regulatory affairs in the pharmaceutical and CRO industries. Sri P Srivastava, PhD, Founder & CEO of ClinTech Research has technical experience related to the full range of pharmaceutical R&D activities. Furthermore, he has substantial project management experience in the pharmaceutical industry in the USA.

Contact us :
CLINTECH RESEARCH India Pvt. Ltd.
Biotechnology Park,
Sector - G, Jankipuram
Lucknow, UP 226021, INDIA
http://www.clintechresearch.com

[Guest-IJT]

Name : DEEPAK G MIRJE
Email : dmirje AT gmail.com
Designation / Skillset : QA/QC Executive/Deputy Manager/In charge/QA/QC Manager
Dear Sir,
Please find attached cv for your reference and found suitable please inform for further interview
Regards,
Deepak M

Resume :
RESUME
Civil Engineering(QA/QC)
EDUCATIONAL BACKGROUND
Bachelor of Civil Engineering, Basaveshwar Engineering College, Bagalkot- India, 1998
Diploma in Civil Engineering, Government Polytechnic Belgaum, India, 1994
NATIONALITY / D.O.B
Indian / 28-07-1975
EXPERIENCE IN CONSTRUCTION INDUSTRY
11 Years
SUMMARY PROFILE :
AN EXPERIENCED QA/QC ENGINEER - QUALITY MANAGER with extensive experience in construction industry for projects such as Industrial, Power Projects, Road Projects (NH4), Commercial, Residential, Airport Terminal Buildings , worked for the Ltd companies such as Afcons, Punj Lloyd, BEB, SPCL, India Bulls, L & T, Arabian Construction Co.
Experienced in the systems adopted in various companies and self refined to discharge & meet customer high quality expectations and imparting to meet Project requirement & Continual Improvement
Key Skills
- QA/QC Inspection activities
- QA/QC Systems ,ISO Systems
- Vendor Inspection & Evaluation
- Internal Audits & effectiveness of QA/QC Systems
- Concretes Works & Testing
- MEP Inspection activities
- Documentation
PROFESSIONAL BACKGROUND :
02/2010 to feb 2011, Arabian Construction Company
U.A.E, Abudhabi
Presidential Palace Project (Marine works)
Senior Quality Engineer
10/2008 to 01/2010, M/S Larsen & Turbo Ltd., E.C.C. Division, Mumbai, India
Project Mumbai International Airport Terminals Buildings
Asst. Manager (QA/QC)
09/2007 to 09/2008, M/S India bulls Real Estate Ltd.
India, Mumbai
Commercial Building Projects
Quality Manager (Civil)
12/2006 to 09/2007, M/S Shapoorji Pallonji & Co. Ltd (India)
West Africa-Accra-Ghana
Project Seat of Government and Presidency
Sr. QA/QC Engineer
11/2003 to 11/2006, M/S B.E. Billimoria & Co. Ltd.
India, Mumbai
Residential, Commercial & Industrial Projects
Sr. QC Engineer
12/1999 to 12/2002,M/S Afcons Infrastructure Ltd.
India, Tarapur
Project Tarapur Atomic Project Power (Unit 3 & 4)
Jr. Engineer (QC)
-It's an Nuclear Power Project at Tarapur consisting of two 500 MW units. It involves Construction of Turbine Building, CCW Tunnels, Fresh water reservoir, Fire water, Reservoir, DM Plant, cable and pipe tunnels / trenches, Pump House etc.
Project cost Appx, Crores 165
Achievements One of the Major Concrete Pour– 2400 cum of Concrete for Deck slab of Turbine Building (Control for Production ,Transportation,& Placing of Temperature control concrete 19 degrees as per specified quality) continuous pour.
RESPONSIBILITIES UNDERTAKEN IN BREIF :
- Inspections ,Monitoring of all construction activities as per Contract conditions, standards, Drawings etc
- Technical submittals approval
- In charge , Concrete Batching Plant
- Co ordination with consultant ,Processor, and third party testing
- Leading team of engineers at Project site
- Site coordination with respect to inspections and approvals
- Fallow up for testing for materials as per specification - outside laboratories
- Review of Project Quality Plan / Procedure / Checklists etc in reference with Tender/Contract Specification/Company Standard Manual
- Implementation of Company Quality Procedure to the Projects
- Conducting regular internal meetings with Team to aware about Implementation of QAQC Systems, Method Statements and its effectiveness.
- Implementation of PQP and Procedures as per contract specification and ISO Standard
- Worked in Tender department for Technical submission of all quality related documents
- Internal Quality Auditing works, Documentation works
- Inspection of Structural steel and Structural Glazing, factory Inspections
- Material Inspection in line with specified standards.
- Ensure corrective action process is established for resolution of Deficiency Reports (DR) and Non-conformance Reports (NCR).
- Monitor Contractor processes.
- Interface with the Contractor’s Quality personnel to ensure that Contractor resolve of issues in alignment with Project requirements.
- Review key vendor quality plans, procedures, and ITP’S.
- Attend selected vendor meetings (History, pre-inspection, in process)
- Review and approve Contractor’s source inspector selection
- Monitor Contractor’s source inspection activities
- Review selected source inspection reports
- Monitors Contractor’s process for tracking of DRs and NCRs being issued.
- Receive quality feedback from sites with regard to Overage, Shortage and Damage issues.
- Interface with sites regarding quality issues & action taken to resolve
- Identifying the need for supplemental source inspection by Company
- Advises and inform quality assistants on quality issues, status and actions
Experience in Road work (NH4)
- Soil testing
- Quarry Inspections, Coordinating with Subcontractor, supplier and conducting pre meets & aware about the project requirements.
- FDD testing by Sand replacement method and Nuclear Density Gauge for Earth work, WMM,GSB
- Control for Production, Transportation & Placing of DLC & PQC as per specified quality
- Documentation work
Concrete Works & Testing
- Involved in Design Mix of various grades of concretes
- Batch Qualification for different Admixtures.
- Testing of concrete ingredients as per I.S. Specification.
- Overall control for production, Transportation and placing of Temperature control
Concrete and high grade concrete using Micro silica as per specified quality.
- Testing of Fresh and harden concrete.
- Interacting with the clients for overall work.
Vendor Inspection
- Conduct pre inspection meetings with vendors providing critical material
- Coordinate inspection activities with Vendors.
- Verify corrective action implemented by Vendor and provide follow up status assessment.
Co-ordinate inspection personnel.
Monitor Inspection personnel performance.
- Review of inspections Reports & Test Reports before final approval
_________________________________________________________________________________
PRESENT LOCATION :
Mumbai
CURRENT EMPLOYER :
Unemployed
PASSPORT VALIDITY :
16/04/2019
EXPECTED SALARY :
As Per Company Norms
JOINING TIME :
Immediate
IDEAL NEXT JOB PREFFERED :
(QA/QC) SENIOR EXECUTIVE/DEPUTY MANAGER/QUALITY MANAGER
AVAILABILITY :
Immediately Now

_________________________________________________________________________________

NAME :
DEEPAK G MIRJE
-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4155622
Date & Time : 20th May 2011 2:40 PM (UTC)
IP Address : 117.204.162.52
Browser Info : Mozilla/5.0 (Windows; U; Windows NT 6.1; en-US) AppleWebKit/534.16 (KHTML, like Gecko) Chrome/10.0.648.204 Safari/534.16
Predicted Country []: India

[Guest]

RESUME
POONAM SHARMA

E-mail- poonambhopal13 AT gmail.com

Career Objective
Aim to grow with the organization and take-up challenging assignments in Clinical Research.

Educational Qualification
- Post Graduate Diploma in Clinical Trial Management from CLINMINDS, Bhopal. (Batch – 2009 - 2010)
- M.Sc. Botany (specialization in cytogenetic) with 64% from Ranchi Women’s College Ranchi.
- B.Sc. Botany Honors’ with 60% from Ranchi Women’s College Ranchi.
Core Knowledge
- ICH GCP
- Schedule Y
- ICMR Guideline
- Protocol Development
- CRF
- Schedule Y1
- Drug Development
- Pharmacology,
- Responsibilities of Key Stakeholders
- Monitoring, Auditing and Inspections
- IND, NDA and ANDA submissions
- ICF process
- Essential Documents
- Clinical trial Design
- Project Management
- BA/BE studies
- Pharmacovigilance
- CDM
- Drug accountability
- PSSV, SIV
- SOP in clinical trial
Working Experince of seven months as Analyst/Research in The Larvol Group (an USA based company)
Job Profile in Larvol
- Clinicaltrials.gov searches
- Primary searches with given url and Key words
- Tagging
- TT update followed by data base entry
- Handling 5 reports with respect to ct.gov search
- Weekly delivery of these reports
Working Experince of Six month as CRC in GLOBAL LIVER AND GASTROENTESTEROLOGY CENTRE.
Internship -At Jawahar Lal Nehru Cancer Hospital, Bhopal ( March 2010)
Under going training on source documentation, EC submission and approvals, IP management, SOP development.
Training under project code-A Phase III, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care verses Best Supportive Care Immediately Following Induction Treatment with Pemetrexed+Cisplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer
Mentor-Mr. Mugil Maurya,
Sr. Study coordinator
Roles and Responsibility
- Assisted in Inform Consent Process
- Maintenance of Excel Charts for Patient Visit
- Ensure Patient Compliance
- Assisted in Quality control system at Site
- Maintenance of Study/ Protocol Specific Logs
- Maintenance of Clinical Trial and Regulatory Binder
- IP Management
- Handling of Biological Substance
- SOP Development
- Assisted in Monitoring Visit
- IP dosing and Compliance
- Accountability of Drugs
- EC Submissions and Approvals
- CIOMS Submission
Assignments undertaken
Protocol development on the topic “Use of STATIN compound in mild to moderate hypertension” & protocol presentation.
SOP development – EC and Site SOP
Presentations - NDA application
E2E “pharmacovigilance planning”,
Anti malarial drugs
Seminar / Conferences Attended
Attended a Seminar on ETHICS COMMITTEE HAVE POWER AND FREEDOM TO OPERATE as an audience conducted by I.S.C.R, North Chapter, New Delhi.
Skill sets
- Good spoken & written communication skills in English.
- Frequent in taking decisions.
- Hard working.
- Adjustable to any new environment.
- Team spirit.
Technical Knowledge
- Conversant with MS Office & internet.
- Windows 98, 2000, XP, Vista.

Extracurricular Activities
Visharrad in classical dance (Kathak)