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
Summary
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
Specialties:
• 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
@ElizabethQuijan
Experience
Quality Compliance Professional, ASQ Certified
Compliance strategy, set-up, and implementation to pharmaceutical and medical device industry
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.
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
Course:
Communication Techniques for Quality Assurance (2011-2012)
Topics: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
Unilever
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
Provided consulting services to pharmaceuticals, biologics, natural health products, cosmetics, disinfectants, active pharmaceutical ingredients and medical devices companies.
Projects:Quality Control Officer
GMP Audit
GMP Training
Annual Product Quality Review Preparation
Development of Standard Operating Procedure (SOP)
Instructor
Academy of Applied Pharmaceutical Sciences
Course: Good Manufacturing Practices (Level I)
Complaints Specialist
Agfa Healthcare
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.
Set up and implemented Quality Management Program
Quality Specialist
Baxter Healthcare
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.
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.
Provided support to the Quality Assurance Manager on the development of Quality Management System that met Health Canada and ISO 9001 certification.
Education
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
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
Scope: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
Scope: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.
This...more
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
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)
BSI
August 2015
Certification # 8282933-142427
Additional Honors & Awards
ASQ CQA (Certified Quality Auditor)ASQ CBA (Certified Biomedical Auditor)
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