Elizabeth Diaz-Penafiel - Pickering, Ontario

Elizabeth Diaz-Penafiel
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About Elizabeth Diaz-penafiel

Elizabeth Diaz-penafiel is currently living in Pickering, Ontario, and is interested in Chemicals, Manufacturing, Med. DevicesPharma.
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Pickering, Ontario

Categories of Interest

Chemicals, Manufacturing, Med. DevicesPharma

My Interests

To pursue new challenges and opportunities within the Pharmaceutical or Chemical Industry

Join Date

Elizabeth Diaz-Penafiel has joined on Apr 10, 2009


Elizabeth Diaz-Penafiel

I graduated with a Bachelor degree in Chemical Engineering and have 19 years experience in the Pharmaceutical Industry, specifically within Quality Operations and Research and Development.

In 1990, I started as a Raw Material Controller at Novopharm Ltd (Teva) in charge of the Quarantine and Release of Raw Materials for the company. I gradually moved up to the position of Finished Good Team Leader in 1998.

In 2002, to pursue new challenges and opportunities I accepted a Research and Development position with Apotex Inc. (Canada's #1 Pharmaceutical Generic Company).
I gradually moved up to the position of R&D Quality Assurance Associate in 2005, responsible for monitoring to assure quality of all operational aspects of the Product Development, Formulation Development and Analytical Development.

I thrive on challenges, I am detail oriented, work well with others, strive for a job well done and will spent the time and effort it takes to succeed. I take comfort in working in a face-paced environment where I can be challenged.

I pursue new challenges and opportunities within the Pharmaceutical or Chemical Industry.

#51-1775 Valley Farm Rd
Pickering, Ontario

Elizabeth Diaz-Penafiel

Objective: To pursue new challenges and opportunities within the Pharmaceutical Industry

Professional experience
2005 - 2009 Apotex Inc Toronto, Canada
Research and Development - Quality Assurance Associate
Responsible for monitoring to assure quality of all operational aspects of the Product Development, Formulation Development and Analytical Development.
Review and analyze Deviations, Laboratory Investigations, Quality Notifications and Change Control documents for R&D.
Review, approve manufacturing and batch-testing results including Certificates of Analysis for R&D Drug Actives, Excipients and Finished Products for all Bio-Submission batches. Audit, approve Certificates of Analysis and assist in the release of Raw Materials and Semi-Finished Products needed for launch preparations.
Assist in the preparation, co-ordination, responding to, and the follow up to Regulatory findings.
Maintain liaison with Regulatory Affairs for documentation required for submissions.
Gain four months experience as a Regulatory Affairs Associate, assist to compile submissions for Canada, US and International (Professional Development Apotex Job Rotation Program).
Gain experience with Microsoft Word and Excel.

2004 - 2005 Apotex Inc Toronto, Canada
R&D Analytical Operations - Analytical Development Senior Chemist
Perform Validation of Analytical testing procedures for Drug Substances and Drug Products.
Assist in Method Development and modifications of Analytical Procedures.
Review Analytical Documentation.
Provide training and troubleshooting services to junior chemists or chemists from other laboratories for any methodology problems.

2002 - 2004 Apotex Inc Toronto, Canada
Research and Development - Product Evaluation Senior Chemist
Perform Comparative Studies on brand and Apotex products using newly developed methods.
Perform testing on Process Validation samples to generate data to enable the optimization or confirmation of the formula.
Perform full testing of Room Temperature, Intermediate and Accelerated Stability samples.
Perform testing and evaluation of new drug substances using compendia and house methods in order to generate data to establish product specifications. Perform alternate raw material supplier evaluations for existing products to establish material suitability and data required for Submission.
Perform and assist with troubleshooting, problem solving in conducting testing which require more skills.

1998 - 2002 Novopharm Ltd - Teva, Scarborough, Canada
Quality Operations - Finished Goods Team Leader
Provide leadership and training to team members.
Perform testing of Process Validation, Finished Goods and Stability samples.
Conduct instrumental and method troubleshooting. Recommend improvements in test procedures and methods.
Participate in the development and implementation of Training and Qualification protocols and the newly created Planning and Logistics group.
Gain experience with Microsoft Word and Excel.

1996 - 1998 Novopharm Ltd Scarborough, Canada
Quality Control Stability Senior Chemist
Perform analysis on the full range of samples for Stability Shelf Life studies using analytical instrumentation such as HPLC systems connected to Millennium network.
Test validation and Method Transfer samples.
Coordinate Placebo Program.
Conduct auditing of QC documentation and perform inspections on Stability Retained samples.
Act as a back up for QC Documentation Auditors and Coordinator of Technical Services.

1994 - 1995 Novopharm Ltd Scarborough, Canada
Quality Control Calibration Chemist
Perform precision, preventative maintenance and calibration on analytical instruments such as HPLC, IR, FTIR, UV/VIS and Dissolution Units.
Coordinate external Service Technicians as required.
Participated in HPB (TPD)/FDA inspections within the laboratory.
Generate Calibration SOPs for laboratory instruments.
Maintain calibration data in an organize format and computerized schedule for instrument calibration.
Gain experience as Coordinator of Technical Services.

1992 - 1993 Novopharm Ltd Scarborough, Canada
Quality Control Raw Material Chemist
Perform analytical methods of analysis including HPLC, GC, UV/VIS, AA, TLC, Electro and Chemical Titration, Optical Rotation, Particle Size, LOD, ROI, Viscosity, Refractive Index, Water by Karl Fisher.
Gain experience in Stability and Coordination of Laboratory Services.

1990 - 1991 Novopharm Ltd Scarborough, Canada
In Process Quality Assurance Raw Material Controller
Coordinate the quarantine and release of Raw Materials for Novopharm.
Maintain liaison with Purchasing, Material Management, Inventory and Warehouses to ensure availability of Raw Materials.
Maintain liaison with Canadian Regulatory Affairs and US for Raw Material documentation required for submissions.
Gain experience with PC and Mainframe programs.

1985 - 1987 Seafood Ltd. , Chile
Chemical Engineer
Coordinate, collate and interpret various equipment data, which was used to identify trends in products.
Review Classical/Instrumental methods and processes to develop efficient and economical production alternatives.
Perform classical and instrumental analyses.

1983 - 1984 University of Santiago, Chile
Research Assistant
Synthesize compounds. Analyze cations in solution through AA.
Perform molecular and ionic studies through X-Ray Diffraction, Electro reduction and Cyclic Voltametry to determine crystallographic, magnetic and chemical parameters.
Perform mathematical, scientific and statistical calculations for reports. Gained experience with Lotus 123, Word Perfect and PC tools.

Education: Bachelor of Chemical Engineering Ty (University of Toronto Evaluation).

Additional Courses:
Quality Notification and Root Cause Corrective Action (CAPA), SAP QM Reviewing, SAP QM Coordination/Approving, Internal System Audit, Batch Record Review Seminar, Manufacturing Documents Review Seminar, Leadership Skills, Empower Software, LIMS Software, Millennium Chromatography Manager Software, Introduction to Pharmaceutical Regulations for Submissions, Global Submission Requirements & the CTD Format, Docubridge - Electronic Submission Software, Content 7.0 Software, Industrial Drug Legislation, Labelling Seminar, RIMS Business Software, Validation of Method, Calibration and Analytical Method of HPLC, Statistics for the non-Statistician, Constraint Management Applications Workshop, Capillary Gas Chromatography, GC Maintenance and Troubleshooting, HPLC, HPLC Troubleshooting, GMPs/cGMPs, GMPs for Clinical Trials, SOPs, WHMIS.

References available on request Phone: (H) 905-420-5083 e-mail:

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Elizabeth Diaz-Penafiel
Name: Elizabeth Diaz-Penafiel
Location: Pickering,Ontario,Canada

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