Quality Assurance Manager

Mandeep Manhas

**** ********** **** ***** : 250-***-****

Victoria B C

V8Z 6B4 Email: *************@****.**

Seeking assignments in pharmaceutical and clinical research organizations with opportunities to effectively use my knowledge and past experience in the industry as well as enhance and acquire more skills.

HIGHLIGHTS

MBBS with MSc in Clinical Research (Cranfield University, UK)3 years of experience in core pharmacovigilance- collection, data entry and case processing of Adverse/Serious Adverse eventsClear understanding and knowledge of ICH GCP, MeDRA, ARGUS, IRMS and ORACLEA keen ability to learn new techniques, tasks and skills.Areas of strength include working in fast paced settings, keen observation, and problem solving skills, proficiency in knowledge sharing, quality assurance and resource managementExcellent interpersonal, communication and organizational skills with expertise in workload management and resource planning.

PROFESSIONAL EXPERIENCE

Study Coordinator April 2012- Present

CookMed Research, Cook Street, Victoria BC, Canada

Managing various clinical trials conducted by the Prinicpal Investigator.Handling diabetic studies from one of the leading pharmaceutical companies in North AmericaTake informed consent, conduct study procedures and report adverse events Maintain Investigator Study File and keep study documentation up to dateArrange for lab technician and make sure all the labs are conducted and shipped within the timelines provided by the sponsorManage and provide study appointments to the patients for site visits as well as phone visitsTrain and supervise new study coordinatorsDesign, update and archive SOPs

Process Trainer January2010- September2011

Pfizer Drug Safety and Surveillance, Wipro BPO (A division of Wipro LTD), Greater Noida, India

Trained 15 Batches as per the client set guidelines.Responsible for training the new hires, officers, Team Leaders and Quality CoachesMade a Training plan to organize the entire Process TrainingClosely worked with the Assistant Manager in conducting audits as well as resolving concerns among the officers and Quality Coaches where there was a difference in opinion observed.Coordinated with different queues- call center, data entry and case processingFirst point of contact for Process related queries, questions and updates.Closely worked with Pfizer Vendor Manager on a day to day basis regarding process requirementsFacilitated in house trainings sessions conducted via video conferencing by the Pfizer training team

Quality Assurance Coach June 2009- January 2010

Quality Assurance Coach with a Span of 25 officers with key deliverables including QC of periodic Adverse Event monitoring forms/regulatory safety reports, feedbacks, team huddles, dashboards and need based trainingsResponsible for overall workload management and resource allocation within the groupWork closely with the Vendor Manager, Pfizer to set departmental strategies and achieve group objectives in terms of key SLAs such as On Time% and Quality Assurance ScoreCoordinator/SPOC – GRnR sessions (Call Calibrations), Internal News Letter - knowledge sharing mechanism, Data Analysis – Top Defects, RCA with CAPA etc

Other Activities – Assisted in hosting internal and external audits, development of processes and procedures to meet global safety reporting requirements and the management of incoming adverse events

Medical Officer September 2008- March 2009

Fortis Clinical Research LTD, Faridabad

Adverse event reporting and monitoring.Overall physical clinical examination of the study subjects.Dosing supervision and monitoring of sample collections.

Lady Medical Officer March 2006- April 2006

Mahindroo Hospital, Uttam Nagar, New Delhi

Assisting in Caesarean sections and other surgical procedures

ACHIEVEMENTS

Rank 1 – Quality Assurance Coach July 2009

September 2009

November 2009

Took over training responsibilities for the new hires January 2009

Certified as a Trainer through Batch Mode Facilitation Skills Program by TT COE (WIPRO LTD)

August 2010

ACADEMIC CREDENTIALS

M.Sc.in Clinical Research, Cranfield University, UK 2009Post Graduate Diploma in Clinical Research Management, (ICRI), New Delhi 2008Bachelor in Medicine and Bachelor in Surgery (MBBS)-Rajiv Gandhi University of Health Sciences, Karnataka, India 2006

PROFESSIONAL TRAININGS

FISH Training – Situational Leadership Development, Wipro LTD4th Annual Conference on GLOBAL TRENDS IN CLINICAL RESEARCH: INDIA 2008 7th Annual Conference of Society of Pharmacovigilance, IndiaPHASE IV clinical trial of a anti rabies vaccineDeformity Prevention Training In Leprosy at District Leprosy Office, BangaloreChikungunya Control Program in the outskirts of Bangalore

OTHER DETAILS

Languages Known : English, Hindi and Punjabi

Computer Skills : MS Office, ARGUS, ORACLE, IRMS

REFERENCES

Will be provided on request.

Mandeep Manhas

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