Quality Assurance Management

David Pradana B.Sc. MBA

*** ********** ****

Toronto, ON M6N 5H8

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

Email: *******@*******.***

Summary of Qualifications

> 10+ year progressive experience in pharmaceutical R&D, IT and Quality

Systems

> Ability to lead successful projects with tight deadlines

> Excellent technical writing and review skills

> Knowledge of compliance and regulatory requirements

> Superior communication, project management, and interpersonal skills

Professional Experience

Apotex Inc., Weston

QA Annual Product Quality Review Supervisor September 2011

- Present

> Manage four associates, including hiring/disposition and

conducting performance reviews

> Schedule and review Annual Product Quality Reviews, track

priorities and monitor due dates

> Perform manager reviews and provide monthly metrics to senior

management

> Core member of the e-signature project overseeing training manuals

and validation test scripts

> Technical lead for the team in applications such as SAP,

TrackWise, and LIMS

> Train team members and promote direct reports development

> Develop, implement and support process improvement initiatives

QA Laboratory Review Project Leader August 2010 -

September 2011

> Approved laboratory investigations, method validation protocols,

and Commercial testing methods across solid and liquid dose sites

> Co-chair in the Compendial Review Committee (CRC)

> Identified potential quality gaps in Quality Systems and worked

with CRC and Commercial group in closing the gaps

> Reported monthly metrics and provided ongoing feedback to

Commercial group

LIMS Consultant (R&D) August 2006 - August

2010

> Configured LIMS with identified changes, including designing,

building and testing static data

> Provided on-going technical support and training to the business

> Wrote and executed validation test scripts

> Assigned and distributed work assignment duty to team members

> Managed five direct reports in LIMS implementation project for

Bangalore plant

Physical Properties Chemist April 2005 -

August 2006

> Conducted physical properties testing and investigation to support

the business

> Prepared physical characterization reports and other technical

reports

> Performed patent and literature searches

> Trained new chemist and helped other chemists in their daily work

Analytical Development Chemist March 2002 -

April 2005

> Performed method validation, evaluation, investigation and

troubleshooting for new analytical test procedures

> Trained junior staff

Seneca College of Applied Arts and Technology, North York

Part-Time Lecturer January 2004 -

September 2005

> Prepared and taught HPLC technical course

Maxxam Analytics Inc., Mississauga

Scientist II October 2000 - March

2002

> Conducted special testing and advanced analysis of compressed

breathing air samples using GC instrument with various detectors

> Supervised in decision-making and report-approving process

Micrylium Labs. (under Lab Support), North York

Chemist August 2000 - October

2000

> Reconstructed IC and HPLC system for preparation of analysis

> Trained and directed new chemist on Dionex system

Riverside Water Quality Control Plant, Riverside

Analyst I

January 1997 - June 2000

> Conducted method validation on TOC and SPE for grease and oil, and

implemented EPA-approved methods to ensure optimization of analysis

California State Polytechnic University, Pomona

Teaching Associate September 1997 -

March 1999

> Lectured students in preparing for laboratory experiments

Education

Master of Business Administration

Schulich School of Business - York University

October 2012

Seneca College of Applied Arts and Technology, North York

December 2006

> Advanced Pharmaceutical Instrumentation Program

> Industrial Pharmaceutical Technology Program

Master of Science in Chemistry

California State Polytechnic University, Pomona

Started 1997

Bachelor of Science in Chemistry

University of California, Los Angeles

December 1996

Community Involvement/Professional Certification

> Casey House Volunteer, 2012 - Present

> United Way GenNext Leaders 2010 - Present

> St. John Ambulance Standard First Aid with CPR Level A, 2009 - Present

> Lean2 Management Training, 2012

> Kepner-Tregoe Problem Solving and Decision Making for Investigations

and CAPA, 2012

> DDI Leadership Development, 2012

> Employee Committee Representative, 2002 - 2011

> Social Director and President for the TLGTA, 2006 - 2009

Language Skills

> Fluent in Indonesian and English

Contact this candidate