DR ANTHONY MELVIN CRASTO,WorldDrugTracker, helping millions, A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair,With death on the horizon, This will not stop me, Gods call only..........
DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai) , INDIA 29Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK PHARMA at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contributio

Wednesday, 14 October 2015

Elizabeth Quijano

Elizabeth Quijano, ASQ CQA/CBA

Elizabeth Quijano, ASQ CQA/CBA

Quality Compliance Professional/ Certified Quality/Biomedical Auditor (ASQ-CQA/CBA)/GMP Trainer/B.Sc. Biochemistry


E-mail: lizquijano@live.com
Tel: 416-843-0611



Process driven Quality compliance professional with 11 years demonstrated experience in GMP compliance strategy, set-up, and implementation related to the manufacturing, importation (MRA and non-MRA) and distribution of pharmaceuticals, biologics, medical devices and natural health products. Extensive knowledge in Current Good Manufacturing Practices (cGMP) for biologics, pharmaceuticals and natural health products, USFDA CFR 210-211, USFDA 820, ICH, Medical Device Regulation, ISO 13485 and ISO 9001, Good Distribution Practices, and Good Pharmacovigilance Practice (GVP).
Certification: Certified Quality Auditor (ASQ)
: Certified Biomedical Auditor (ASQ)
Education: B.Sc. Biochemistry
• Regulatory inspection
• Regulatory communication
• Establishment/Site Licensing
• GMP audit
• GMP training
• Product Release (i.e. BGTD Lot Release, Special Access Programme)
• Product Testing (i.e. Stability, Confirmatory, Identity)
• Quality Management System (i.e. Deviation, Corrective/Preventative Action (CAPA) and Out of Specification (OOS) Investigation, Change Control, Complaint and Adverse Reaction)
• Quality Agreements
• GMP Compliance (i.e. Validation, Annual Product Review, Batch Record Review, Alternate Sample Retention, Unique ID Certification)
• GMP records (i.e. Standard Operating Procedure, protocol, reports, checklist)
• Logistics GMP (i.e. Transportation Studies)
 Liz Quijano

Liz Quijano



Quality Compliance Professional, ASQ Certified

Compliance strategy, set-up, and implementation to pharmaceutical and medical device industry
2015 – Present (less than a year)Canada
Manage activities related to company's compliance to GMP or Medical Device Regulation. This will include GMP audit, Training, Change Control, CAPA, Complaint and Adverse Event, RECALL,
Annual compliance (i.e. Stability and Confirmatory testing, Annual Product Quality Review, Batch Record Review, Annual Validation Summary Reports) ,develop GMP records (i.e Quality Agreement, Standard Operating Procedures) and product release. Host regulatory inspections.
Continuously improve the overall quality system. Track quality assurance metrics for the organization. Manage relationship with vendors and regulatory authorities. Manage all activities specific to Establishment/Site Licensing.

Continuing Education Professor

Humber College
2011 – Present (4 years)Ontario, Canada
Communication Techniques for Quality Assurance (2011-2012)
Business Correspondence
How to write SOP
How to write informational, analytical and recommendation report
How to write positive, negative and persuasive message
Listening skills
Team Dynamics
How to deliver presentation
How to provide feedback

Senior Quality Lead

2013 – 2015 (2 years)Toronto, Ontario, Canada
Managed all activities related to Unilever’s compliance to all applicable Health Canada regulation for the importation and distribution of DIN and NHP products. Ensure foreign sites, warehouse and laboratories are in compliance to Canadian GMP. Managed all activities specific to Establishment/Site Licensing application/amendment and renewal of Unilever Canada, foreign sites and warehouse.

QA Consultant

PharmEng Technology
2012 – 2013 (1 year)Ontario, Canada
Provided consulting services to pharmaceuticals, biologics, natural health products, cosmetics, disinfectants, active pharmaceutical ingredients and medical devices companies.
Quality Control Officer
GMP Audit
GMP Training
Annual Product Quality Review Preparation
Development of Standard Operating Procedure (SOP)


Academy of Applied Pharmaceutical Sciences
2012 – 2012 (less than a year)Ontario, Canada
Course: Good Manufacturing Practices (Level I)

Complaints Specialist

Agfa Healthcare
2011 – 2012 (1 year)Waterloo Ontario Canada
Reviewed complaints for appropriateness of root cause analysis, completion and effectiveness of Corrective and Preventative Action (CAPA) and compliance to all applicable regulations and current procedures.

QA Manager

Summit Veterinary Pharmacy Inc.
2010 – 2011 (1 year)Toronto, Ontario, Canada
Set up and implemented Quality Management Program

Quality Specialist

Baxter Healthcare
2006 – 2010 (4 years)Toronto, Ontario, Canada
Managed all activities related to product release and compliance of biologics, drug imports (MRA and non-MRA), medical devices, clinical trial products and Special Access Programme (SAP) products to GMP, Medical Device Regulations and Baxter Quality Management System. Oversee UPS-SCS compliance to GMP, Medical Device Regulations and Baxter Quality Management System.

QA Manager

Pax-All Manufacturing Inc.
2004 – 2006 (2 years)Toronto, Ontario, Canada
Managed all activities (i.e. release, development of specifications, deviation and CAPA, complaints, supplier non-conformances, in process testing, batch record review) related to Pax-All’s compliance to ISO 9001, Health Canada Good Manufacturing Practices and customer requirements for the manufacture of Category IV monograph and Natural Health Products.

Laboratory Technician

Pax-All Manufacturing Inc.
2003 – 2004 (1 year)Missssauga, Ontario, Canada
Provided support to the Quality Assurance Manager on the development of Quality Management System that met Health Canada and ISO 9001 certification.


Humber College

Quality Management Program

Course Taken:
Quality Concepts
Quality Auditing
Six Sigma

Seneca College of Applied Arts and Technology

Certificate, Regulatory Affairs and Quality Operations

Course Taken:
Pharmaceutical Manufacturing and Formulation
Regulatory Affairs Level I and II

Volunteer Experience & Causes

Workshop Provider

American Society for Quality (ASQ)
November 2012Education
Title: Effective Business Correspondence
This course focused on one of the most basic type of communication that happens in the workplace, business correspondence. In this course, participants learned the different types of correspondence common in the workplace and their uses, the process in writing correspondence, how to write correspondence that will obtain the maximum audience...more

Workshop Provider

American Society For Quality (ASQ)
May 2013Science and Technology
Seminar: Handling Regulatory Inspection In The Pharmaceutical Industry
This interactive seminar focused on strategies for handling regulatory inspection in the pharmaceutical indsutry . In this seminar, participants got an overview of the audit process, how to prepare their facility and personnel for an audit, audit do’s and don’ts, and how to respond to audit questions.

Designation: Competent Communicator (CC), Advanced Leader Bronze (ALB)

Toastmasters International
2011 – Present (4 years)Education
o President, U-Toast Club, 2014-2015
o Vice President Education, U-Toast Club, 2013-2014
o President, Power Speaking Club, 2013
o Vice President, Public Relations, 2012
o Club International Speech Contest (1st Place), 2013
o Club Humorous Contest (1st Place), 2012
o Event Speaker at District 86 Speakers Bureau, 2012-2013

Honors & Awards

ISO 13485:2003 Lead Auditor (TPECS)

August 2015
Certification # 8282933-142427

Additional Honors & Awards

ASQ CQA (Certified Quality Auditor)
ASQ CBA (Certified Biomedical Auditor)


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