available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese CMOs in order to ensure quality of pharmaceuticals and cosmetics under the regulatory compliance as a manufacturing and marketing authorization holder.

Mission of the EMQA:

Ensure that manufacturing and quality control in local toll manufacturers complies with Japanese GMP requirements and IQC Directives from a GQP perspective and contribute to the improvement of product quality and safety.

Objectives:

Good Quality Practices (GQP) activities - GQP is a unique system defined in Japanese PAL.

GQP activities are necessary to ensure the appropriate management of quality for products & systems as MAH.

It includes document management (SOPs, records…), supplier/manufacturer management, batch release for the market, risk management for quality events, and any other relevant activities.

KNOWLEDGE AND SKILL REQUIREMENTS

• Education/training regarding GQP, GMP and GDP.
• Knowledge of Japanese pharmaceutical laws, regulations and requirements related to CMC and QA.
• Experience of Vaccines/Biologics, and sterilization
• Audit execution skill
• Negotiation and good communication skill
• Fluent in English and Japanese
• Able to go to working locations in Japan : Tokyo Hatsudai (Sanofi office) and regular visits of CMOs in Japan

​Knowledge And Skills Desirable But Not Essential:

• Regulatory (Direction insert, Label, Package of Artwork e.t.c)
• Chemistry (HSE, SDS e.t.c)

PRINCIPAL DUTIES AND RESPONSIBILITIES

Collaboration:

• Prepare and participate in the project meeting for the new product launch to identify and plan the Quality actions needed for timely launch.
• Collaborate with EM Project team for the new product launch plan execution and continuously update the progress on Quality topics
• Prepare the plan for Quality task through collaboration with Sending site Quality, CMO Quality, GQP and Affiliate regulatory.
• Prepare and align CMO for the NDA submission plan and task needed for execution at CMO through collaboration with Affiliate regulatory and GQP.

Due diligence:

• Participate and plan Quality due diligence through planning Quality audits of identified CMO.
• Ensure the CMO approval and Quality Due diligence performed.
• Participate and support CMO in PAI inspection planned at CMO through coordination with Affiliate regulatory.

Method transfer and validations:

• Apply MRA /MOU for the new product launch
• Plan and coordinate the Analytical method transfer from sending site to CMO Quality.
• Coordinate and align and approve transfer protocol from Sender site to CMO as per Sanofi guidelines.
• Align the Specifications in AMT as per the NDA dossier plan for submission through collaboration with Regulatory.
• Perform and approve the product validation plan with CMO.
• Perform the shipping validation with the Sender site and align the Japan market regulation in validation protocol.
• Coordinate and participate the shipping validation of drug product from CMO to distribution center through collaboration with supply chain team member.
• Coordinate and arrange the samples required for method transfer from sender site to CMO’s

QTA /PTS :

• Ensure Quality agreement and product technical specifications are approved before launch timely manner.
• Align Quality agreement and Product technical specification with API supplier as per Sanofi Guideline
• Align Quality agreement and Product technical specification with Bulk product supplier as per Sanofi Guideline
• Align Quality agreement and Product technical specification with CMO as per Sanofi Guideline.
• Collaborate with GQP members for Quality agreement and product technical specification (as per Dossier).
• Prepare and align The Visual inspection specifications and standards with Bulk manufacturing site and GQP.
• Align COA and COC format for bulk supplies for the product as per the registered dossier.
• For Vaccine and Biological product ensure the valid and approved NIID protocol from Affiliate regulatory , GQP and NIID testing lab authority is available at CMO timely manner

Validation Support at CMO site:

• in case of Vaccine and biologic products ensure the CMO oversite by CMO site visit.
• Participate at CMO site for the oversite of validation batches and ensure smooth transfer during the Method transfer as well as validation activity.
• Management of deviations on bulk samples and during the transfer and validation activity through collaboration with sender site, GQP and CMO quality.

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