Vinita Thakur, Ph.D (Biochemistry)

Phone: 1-647-***-****

ac3ilv@r.postjobfree.com

https://www.linkedin.com/in/vinita-thakur-088bab81/

APPLICATION FOR THE POSITION OF REGULATORY AFFAIRS DIRECTOR (Pharma) - 3085 in Toronto, ON, M3C, Canada

CERTIFICATIONS

Certified Auditor, ISO 15189:2012

Certified Internal and external auditor, ISO 17025:2005

Internal Auditor, ISO 9001:2000

HIGHLIGHTS OF QUALIFICATIONS:

More than 20 years experience of quality assurance leading a quality team to handle operation of an accredited laboratory

Trained in Indian Pharmaceutical company to understand the quality assurance and regulatory functions

Trained in Canadian lab Dynalife lab, Edmonton for Tandem mass spectrometry in metabolic profiling, Clinical Chemistry, Quality Management System, Serum protein electrophoresis for myeloma detection and Hemoglobinopathies

More than 10 years of Quality Assurance experience with 5 years experience managing direct reports

More than 5 years of regulatory exposure as a Senior Quality Manager

Extensive audit/audit response background

Highly developed quality, regulatory and production mindset including an appreciation for client service and contract manufacturing

Exceptional Good Manufacturing Practices knowledge

Demonstrated decision making capabilities. Well organized and detail oriented

Strong leadership and conflict resolution skills. Demonstrated ability to balance/maintain conflicting goals, responsibilities, and priorities of the organization

Demonstrated success as agent of change. Excellent interpersonal and communication skills, as well as the ability to motivate and lead

Experience with Microsoft Word and Excel

Proficiency in the English Language

Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence

PROFESSIONAL EXPERIENCE

PHARMACEUTICAL EXPERIENCE

Montage laboratories, India 1995-1996

Trained in Indian Pharmaceutical company to understand the quality assurance and regulatory functions

Experience in managing teams to assess ongoing and future training, and development needs and effectiveness of established programs

Training program development to provide training as needed and in locations that work for the participants

Excellent internal communication skills to focus on providing engaging communications about program information to encourage participation and highlight the value and benefits of training

Developing and approving new training techniques and enhancements to existing training programs

Established relationships with vendors to provide additional outside training programs

Manage and develop training professionals

Solid professional experience in commercial and training & development areas

Can create functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure

HOSPITAL & HEALTHCARE INDUSTRY

Batra Hospital & Medical Research Center, Delhi 1996- Aug, 2017

Senior Consultant and Head, Clinical Biochemistry

Validation of Automated Chemistry Analyzers, helping in preparing IQ, OQ and PQ of analyzers

Set up the quality control protocols, quality indicators and quality improvement procedures

Resolved customer’s complaints, identifying the error and doing CAPA

Looked after the Immunoassays, strategically adding new immunoassays to increase the work load

Involved in teaching and training of technical staff, Medical and nonmedical student graduates and nursing staff

Mentor for thesis work

Gave presentation of research work in various conferences and meetings

Involved in writing research protocol, reports and publications, reviewer and editorial board Member for international journals

Consultation to physicians, patients and other users of lab

AUDITOR & TRAINER

National accreditation board of laboratories and medical testing (NABL), India

Technical Assessor, Clinical Biochemistry

Performing audits of medical labs for ISO Accreditation as per 15189: 2012

Internal Auditor, ISO 17025 and 9001,Hospital labs

Audits of hospital labs for accreditation as per 15189 and 9001

Trainer for ISO accreditation and GLP processes

Imparting training for ISO accreditation to lab technologists and hospital staff

Imparting training to Nursing staff of the hospital

Imparting training to staff of medical device company for NABL accreditation

MEDICAL DEVICE MANUFACTURING INDUSTRY

Expert and quality advisor

Instrumentation Lab, USA (IL), India 2016- July 2018

Consultant for the Quality system and quality control

Worked on the project “Intelligent Quality Management system (IQM) for GEM 3500/4000 blood gas analyzer in India”

Introduced “Intelligent quality management”,a new concept in automated quality system for blood gases in laboratory

Checked the credibility of IQM system by comparing with external QC and calculating % CV

Trained IL application specialist about the IQM, validation protocols for their machine to prepare IQ, OQ,PQ and other quality assurance procedures

Helped company to introduce this system to NABL, apex accreditation authority of India for certification by ISO 15189:2012

Pioneer in obtaining approval from NABL to run this system on POC devices in Indian laboratories, this helped company to increase the sale of this system in India

Expert Speaker in medical conference and business meetings about the Intelligent Quality Management system (IQM)

Polymedicure Vacutainers Pvt Ltd, India 2015-2016

Trained and Taught staff for introducing safety features in their blood collection device

Advisor for production line of vacutainers and choice of appropriate anticoagulant in their tubes

Arranged regular CMEs in hospital to increase the awareness of their products

Worked as invited speaker for utility of vacutainer system in blood collection in Polymed national business meets

Trained their national sales team and suppliers about ISO requirements in a clinical lab to minimize the out of specification and perform CAPA

KPS Clinical Services Pvt Ltd (CRO), Delhi 2014 -2016

Expert for study design and method validation for clinical trials

Wrote a validation protocol for methods used in various phases of clinical trials

Selection of Investigators for various Phases of studies

Selection of volunteers required

Preparation of QC documents required for audit purposes

VOLUNTEER WORK

North American College of Pharmaceutical Technology/Validation Tech Inc,

Toronto, Ontario, Canada May- June, 2017

Instructor (part time)

Helping in method validation experiments for HPLC

Planning and preparing presentations

Provide training to professionals

Marking and Evaluation

Establishing and maintaining working relationships

Participating in staff meetings, networking events and other activities as needed

EDUCATION

Ph. D, AIIMS, New Delhi 1996

CANADIAN AND AMERICAN CREDENTIAL EVALUATION

University of Toronto 2010

ECE, Wisconsin 2013

RELEVANT TRAINING

2015 Training in metabolic profiling by GCMS, Neocare lab, Mumbai

2012 Capillary electrophoresis training by Sebia, France, BHMRC

2009 Training in Tandem mass spectrometry in metabolic profiling,

Clinical Chemistry, Quality Management System, Serum

protein electrophoresis for myeloma detection and Hemoglobinopathies, Dynalife lab, Edmonton, Canada

2006 Bayer Healthcare Notre Dame Executive Management Programme

for clinical labs, University of Notredame, South bend, USA

2005 Training and visit to Core Clinical Laboratory, AACC travel grant

programme, Riverside hospital core lab,Columbus,USA

2003 Training on Tissue culture, luminometry and flow cytometry

techniques, Cancer Research Institute of West Tenneessee,

Henderson, USA

1999 Training On Molecular Techniques, HLA-DNA Laboratory, St.

Mary’s Hospital, London, U.K. 1999

AWARDS & DISTINCTION

2011 Biography published in Marquis Who’s who in world

2009 Canadian Society of Clinical Chemistry-Roche International Travel

Award

2008 IFCC-Roche travel scholarship and bursary, IFCC World lab Brazil

2007 Biography published in Marquis Who’s who in Asia

2007 Bursary award, 17th IFCC - FESCC NVKC, Amsterdam. Holland

2006 Bursary award, XVth Serbian congress of Medical Biochemistry and

Laboratory Medicine with international participation, Belgrade,

Yugoslavia

2005 Gallawas International Travel Grant Award, IFCC world

Congress, USA

2004 Regional Service Award, APCCB, Perth, Australia

2003-2008 Gallawas membership award for AACC

2003 ACBICON Award, ACBI India

2002 KYOTO ASIA A Award, ICCC), Kyoto, Japan

2000 Bursary Award, Chinese Congress of Clinical Chemistry, Hong

Kong China

1999 IFCC-BURSARY Award, IFCC, Italy

OTHER DETAILS ON PUBLICATIONS AND PRESENTATIONS CAN BE PROVIDED UPON REQUEST

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