Fathima Ifthiya Rixzan

Fathima Ifthiya Rixzan Email and Phone Number

Senior QA Consultant at DSA Consultants @ DSA Consultants
oakville, ontario, canada
Fathima Ifthiya Rixzan's Location
Greater Toronto Area, Canada, Canada
Fathima Ifthiya Rixzan's Contact Details

Fathima Ifthiya Rixzan work email

Fathima Ifthiya Rixzan personal email

n/a
About Fathima Ifthiya Rixzan

My former colleagues have been impressed with the industrial expertise that I carry and my critical thinking capacity in the allied field. I have solved numerous processes and product related complicated problems and trained many Seneca and Humber colleges’ interns on Quality and Compliance A highly resourceful and articulate team player who collaborates effectively with all levels of management, staff and clients. Committed to the provision of the highest levels of quality and service excellence. My diverse background in quality and compliance industry ranges from packaging operator to quality and compliance auditor. I have designed scientific study protocols such transportation validation, stability and temperature mapping, drafted vendor quality agreements, conducted root cause analysis for deviations, CAPA and initiated many change controls. I am an expert in Good Manufacturing Practice related documentation reviews to compliance audits. Moreover, I have interacted with 3PL services to provide business continuity plans and navigate them to be compliance with GMP and Golden Standards set by company Quality Management Systems. I am Quality Assurance Personnel with a strong scientific background and over 10 years of field experience in natural health products, pharmaceutical and medical device. Specializing in monitoring product performance through an integrated approach of applicable GMP, Medical Device Standard and Regulatory requirements and process improvement initiatives. I assist companies with their inspections and manage requests from regulatory authorities. My specialties are Product Release, Change Management, Formulating Testing Specifications, Deviations, Root cause analysis, Batch Records Review, Temperature Excursion and Temperature Mapping Studies, GMP inspections, Internal Audit, Supplier Qualification, Annual Product Quality Review, Product Complaints, and Product launch.

Fathima Ifthiya Rixzan's Current Company Details
DSA Consultants

Dsa Consultants

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Senior QA Consultant at DSA Consultants
oakville, ontario, canada
Employees:
10
Fathima Ifthiya Rixzan Work Experience Details
  • Dsa Consultants
    Senior Qa Consultant
    Dsa Consultants Aug 2018 - Present
    Oakville Ontario Canada
    Releasing drug product to Canadian market. Reviewing GMP documentations such master production documents, validation & stability protocols & reports and batch related documentations. Conducting Annual File Reviews. Designing Transportation and Storage Validations. Initiating Quality Performance indicators: CAPA, Deviations, and Change Controls.
  • Scican
    Quality Control Supervisor, Drugs
    Scican Jan 2015 - Jan 2018
    Toronto, Canada Area
    Released drug product to the Canadian market, Responsible for recall issues. Handled deviations, CAPA, Change Controls, Self Inspection, SOP and GMP refresher. Supplier and Importer Specific APQRs. Designed transportation and storage validations and stability studies. Reviewed GMP related documentation such as masters and real time production records. Generated stability and finished product testing specifications. Conducted internal and vendor quality audits. Rolled out quality assurance… Show more Released drug product to the Canadian market, Responsible for recall issues. Handled deviations, CAPA, Change Controls, Self Inspection, SOP and GMP refresher. Supplier and Importer Specific APQRs. Designed transportation and storage validations and stability studies. Reviewed GMP related documentation such as masters and real time production records. Generated stability and finished product testing specifications. Conducted internal and vendor quality audits. Rolled out quality assurance agreements. Show less
  • Experchem Laboratories Inc.
    Quality Control Associate - Team Lead
    Experchem Laboratories Inc. Feb 2013 - Jan 2015
    Toronto, Canada
    Pharmaceutical industry professional with 20 plus years e progressively experience in quality control, validation, and quality assurance. Managing quality and compliance related project basing best applicable regulations, industrial practices, analytical and problem solving skills. Actively participating and aiding internal and external audits. Strong working knowledge of label reviews of drugs, medical devices and natural health products for existing and new drugs and devices… Show more Pharmaceutical industry professional with 20 plus years e progressively experience in quality control, validation, and quality assurance. Managing quality and compliance related project basing best applicable regulations, industrial practices, analytical and problem solving skills. Actively participating and aiding internal and external audits. Strong working knowledge of label reviews of drugs, medical devices and natural health products for existing and new drugs and devices. Specialized: Method, cleaning and process validations study designing and reviews as per the applicable guidelines, actively participating in annual product quality reviews per the Canadian, US GMP and EU pharmaceutical regulations. Actively conducted reviews of master productions, batch production records. Adapted checklists for reviews such as validations, APQRS, BPRs, and Quality Management Systems. Show less
  • Eurofins - Experchem
    Quality Control Associate
    Eurofins - Experchem Sep 2005 - Feb 2013
    Toronto, Canada Area
    Reviewed GMP documentation such as batch production records, generated stability and finished product specifications, conducted annual product quality reviews, initiated change controls. and CAPA, Designed storage validation protocols. Reviewed validation protocols and reports.
  • Sanofi Pasteur
    Aseptic Packaging Operator
    Sanofi Pasteur Mar 2004 - Mar 2005
    Sampling, Batch production record reconciliations, verification of packaging components for the order.
  • Glaxosmithkline Canada
    Pharmaceutical Line Operator
    Glaxosmithkline Canada 2003 - 2004
  • State Pharmaceuticals Corporation Of Sri Lanka
    Technical Assistant
    State Pharmaceuticals Corporation Of Sri Lanka Jun 1994 - Jul 2001
    Review of GMP related documentations. Generating test specifications. Handling complaints.

Fathima Ifthiya Rixzan Skills

Gmp Sop Validation Capa Glp Fda Lims 21 Cfr Part 11 Change Control Pharmaceutical Industry Hplc Quality Assurance Quality System V&v Quality Control Good Laboratory Practice Standard Operating Procedure

Fathima Ifthiya Rixzan Education Details

  • University Of Peradeniya, Sri Lanka
    University Of Peradeniya, Sri Lanka
    Industrial Chemistry
  • Toronto Institute Of Pharmaceutical Technology
    Toronto Institute Of Pharmaceutical Technology
    Pharmaceutical Quality Control

Frequently Asked Questions about Fathima Ifthiya Rixzan

What company does Fathima Ifthiya Rixzan work for?

Fathima Ifthiya Rixzan works for Dsa Consultants

What is Fathima Ifthiya Rixzan's role at the current company?

Fathima Ifthiya Rixzan's current role is Senior QA Consultant at DSA Consultants.

What is Fathima Ifthiya Rixzan's email address?

Fathima Ifthiya Rixzan's email address is fa****@****lab.com

What schools did Fathima Ifthiya Rixzan attend?

Fathima Ifthiya Rixzan attended University Of Peradeniya, Sri Lanka, Toronto Institute Of Pharmaceutical Technology.

What skills is Fathima Ifthiya Rixzan known for?

Fathima Ifthiya Rixzan has skills like Gmp, Sop, Validation, Capa, Glp, Fda, Lims, 21 Cfr Part 11, Change Control, Pharmaceutical Industry, Hplc, Quality Assurance.

Who are Fathima Ifthiya Rixzan's colleagues?

Fathima Ifthiya Rixzan's colleagues are Maria D., Charles Boampong, Dev Sharma, Ron Frazer.

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