Mortazavi - Technology Transfer - North York, Toronto, ON, Canada

Niaz Mortazavi

North York, Toronto, ON, Canada

Services

Technology Transfer

Summary:

SANOFI
Technology Transfer and Process Support Deputy Manager 2013 – 2014
• Conducted Technology Transfer for local manufacturing of SANOFI products (Taxotere for the first time in Middle East, Plavix, Telfast, Stilnox, Depakine).
• Planned and managed, with maximum efficiency, all Technology Transfer projects and Manufacturing Processes for the products in the local manufacturing plan by using MSP Detail Planning and Daily follow up.
• Led Scale-up of Technical & Validation batches in clean room area & Isolator for sterile Products and in controlled conditions for Solid Dosage, Semi solid or liquid dosage ensuring that all condition & specifications meet SANOFI requirements.
• Managed stock availability of Materials and consider delivery lead time in management of Project.
• Conducted projects by handling meeting & teleconferences (TCs), and follow sub-tasks by Microsoft project and RACI chart and Risk assessment to find critical tasks in each project and define second scenario to be in safe side and to have minimum deviation from project timeline.
• Trouble shooting of pharmaceutical manufacturing processes, solving problems in critical situation ensuring that Project goes though time planning.
• Prepared SOPs and documentations like Batch Manufacturing Record (BMR), Validation Master Plan (VMP), CVMP, Media fill protocols, process validations protocols and reports, transport validation & Technology Transfer protocol ensure timely execution of protocols and provision of results in accordance with cGMP and SANOFI standards.
• Developed & modified Facilities of third parties to meet SANOFI requirement for new product launches.
• Conducted qualification team to perform filling line & gassing validation, dose validation, qualification of Autoclaves, and validation process from HSE view point.
• Report Quality development and Technology Transfer Activities, SANOFI quality KPIs and Risk ranking of subcontractors.
• Ensure compliance of the

Work History

Technology Transfer and Process Support Deputy Manager

SANOFI

Conducted Technology Transfer for local manufacturing of SANOFI products (Taxotere for the first
time in Middle East, Plavix, Telfast, Stilnox, Depakine).
• Planned and managed, with maximum efficiency, all Technology Transfer projects and Manufacturing
Processes for the products in the local manufacturing plan by using MSP Detail Planning and Daily
follow up.
• Led Scale-up of Technical & Validation batches in clean room area & Isolator for sterile Products and in controlled conditions for Solid Dosage, Semi solid or liquid dosage ensuring that all condition & specifications meet SANOFI requirements.
• Managed stock availability of Materials and consider delivery lead time in management of Project.
• Conducted projects by handling meeting & teleconferences (TCs), and follow sub-tasks by Microsoft
project and RACI chart and Risk assessment to find critical tasks in each project and define second
scenario to be in safe side and to have minimum deviation from project timeline.
• Trouble shooting of pharmaceutical manufacturing processes, solving problems in critical situation
ensuring that Project goes though time planning.
• Prepared SOPs and documentations like Batch Manufacturing Record (BMR), Validation Master Plan
(VMP), CVMP, Media fill protocols, process validations protocols and reports, transport validation & Technology Transfer protocol ensure timely execution of protocols and provision of results in accordance with cGMP and SANOFI standards.
• Developed & modified Facilities of third parties to meet SANOFI requirement for new product
launches.
• Conducted qualification team to perform filling line & gassing validation, dose validation, qualification of Autoclaves, and validation process from HSE view point.
• Report Quality development and Technology Transfer Activities, SANOFI quality KPIs and Risk
ranking of subcontractors.
• Ensure compliance of the projects with GMP and EMEA standards, monitoring of the production
standards and...

Head of Project Quality & GMP, Industrial Affairs, Quality and Compliance

SANOFI

Navigated and controlled quality in local manufacturing of SANOFI products to meet GMP and
SANOFI requirements for both Solid Dosages and Sterile Products.
• Executed qualification of Clean room and Isolator, ensuring sterility of the products.
• Supervised installation of EMS (environmental monitoring system) in third party site and controlled
monitoring before, during and after production, to ensure no contamination exists.
• Led Quality requirements of Technology transfer for local manufacturing Taxotere one vial 20mg and 80mg, Plavix, Telfast, Stilnox, Depakine 200mg and Depakine Chrono 500 mg.
• Supervised Media fill run of Taxotere for the first time in Third party filling line ensuring no microbial
growth in manufacturing process.
• Organized Analytical transfer between SANOFI Donor Sites & third parties ensuring that analytical
method verified and validated.
• Handled customer complaints and follow up to report the results to customers based on PTC.
• Inspected validations and qualifications of different process. Inspect production on a weekly basis
ensuring customers receive quality products.
• Organized Quality audit and scheduled follow up of corrective actions to achieve quality improvement.
• Developed Sourcing case for new product launches ensuring feasibility based on capacity analysis.
• Initiated Quality Agreement between SANOFI and Third Parties for local manufacturing.

Qualification & Validation Manager in QA

Jaber Ebne Hayyan pharmaceutical company

JEH Company is Iranian pharmaceutical Co. active in producing Generic Antibiotics and Inhaler products.

• Conducted research to develop new analytical methods with HPLC for antibiotic Raw Material & FP.
• Revised & Controlled of DMFs (Drug Master Files, Dossiers)
• Implemented quality management systems such as ISO 9001-2000 & ISO 17025, OHSAS 18000 and IMS Planned
internal audit and audited as a certified auditor.
• Led Validation and qualification team to valid pharmaceutical processes for solid dosage & Aseptic filling
processes
• Initiated Validation Master Plan and Site Master File.
• Performed Cleaning validation and prepared cleaning validation Master plan, in parallel with developing method for detecting residual material with low LOD based on PICS & ICH guideline.

Quality Assurance Specialist

Jaber Ebne Hayyan pharmaceutical company

• Controlled and revised of Drug Master Files for regulatory affairs.
• Developed Analytical methods validation.
• Followed up Product Complaints through the specific system & scheduled of follow up and report the results to customers.
• Develop & update SOPs and working instructions related to opertion, QA & QC and Supply Chain.

Qualifications & Certifications

Chemistry

Shahid Bahonar University of Kerman

Applied Chemistry

K.N. Toosi University of Technology of Tehran

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