Experience

Sandoz Canada
• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Senior Quality Assurance Manager

  • Oct 2023 - Present


Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Quality Assurance Manager

  • Nov 2014 - Present

  -Responsible for managing all quality aspects at external suppliers for Pharmaceuticals and to ensure that the operational business is in compliance with cGMP.-Implement strategies and processes and exercise oversight to ensure that GMP activities conducted for marketed products are found compliant to all applicable Canadian regulations (and other applicable regulations such as FDA and others) and Novartis Standards.-Oversee product release activities for marketed products in Canada.-Coordinate new product launches and site transfers ensuring all documents and QA systems are in place for a quick release without any quality issues. Provide technical support for product divestment. Show less

• Quality Assurance Specialist

  • Jun 2010 - Nov 2014

  -Managing critical quality issues (deviations, out-of-specification results, complaints, recalls, counterfeits, stability failures, etc) -Managing new product launches and site transfers -Review of batch docurments and release products to market in compliance with registered specifications and GMP-Managing quality related activities at the External Supplier



Cobalt Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Compliance Specialist, Cobalt Pharmaceuticals Inc

  • May 2009 - Jun 2010

  -Compiled and reviewed Compliance files for Cobalt's products: QA documents related to product release, regulatory submissions, deviations, stability and artwork -Technically assessed and approved change controls both internally and those received from third parties -Provided Quality Oversight to Contract Manufacturers/Packagers to asses quality issues, change requests, and submission requirements -Performed vendor,contract manufacturer/packager and contract laboratory audits -Compiled and reviewed Compliance files for Cobalt's products: QA documents related to product release, regulatory submissions, deviations, stability and artwork -Technically assessed and approved change controls both internally and those received from third parties -Provided Quality Oversight to Contract Manufacturers/Packagers to asses quality issues, change requests, and submission requirements -Performed vendor,contract manufacturer/packager and contract laboratory audits



Patheon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Compliance Auditor

  • Apr 2006 - Jun 2009

  -Hosted comprehensive GMP inspections conducted by Patheon's world wide clients (Pharmaceutical companies) and Regulatory Agencies: FDA,HPFBI, ANVISA,COFEPRIS etc. As a contract manufacturer Patheon Inc. received approximately 50 client audits annually -Coordinated audit responses: entered reports in database, ensured all responses are compiled and provided to the Regulatory Agency/Client in a timely manner -Reviewed deviation reports including complaint cases investigations -Provided GMP guidance for the US, Canadian and European markets for all the areas of the manufacturing, testing and packaging operations -Conducted internal audits and external GMP audits - Performed GMP Training at required intervals Show less



Galenika A.D.

• 1 - 100 Employee

• Senior Associate Quality Department

  • Mar 2003 - Jan 2005

  -Responsible for setting up validation policies company wide and supervised validation activities in the production area -Evaluated and approved validation protocols and reports -Led cleaning validation activities -Responsible for setting up validation policies company wide and supervised validation activities in the production area -Evaluated and approved validation protocols and reports -Led cleaning validation activities



Genpharm Inc.

• Philippines
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Data Reviewer

  • Jan 1997 - May 2002

  -Reviewed analytical method validation data and generated validation reports for submission to Regulatory Agencies -Compiled and conducted reviewing of analytical data generated in the QC Laboratory -Reviewed analytical method validation data and generated validation reports for submission to Regulatory Agencies -Compiled and conducted reviewing of analytical data generated in the QC Laboratory



Torpharm Inc

• Pharmaceutical Manufacturing

• Laboratory Analyst I R&D Laboratory

  • Jul 1995 - Jan 1997

  -Analyzed a wide variety of raw materials,in-process and finished products -Developed and validated analytical methods -Analyzed a wide variety of raw materials,in-process and finished products -Developed and validated analytical methods