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CHC Distributors Quality Lead - International Region

Synthorx

Synthorx

Quality Assurance
Multiple locations
Posted on Friday, August 25, 2023

Job Title: CHC Distributors Quality Lead – International Region

Location: Hyderabad

Role Purpose

Support the Business Teams in charge of the management of Distributors (in the assigned countries selected for a Distributor Business Model set-up) by ensuring an appropriate quality oversight/level of control on those Distributors.

Roles & Responsibilities

  • Operational management of all quality matters reported by/impacting the local Distributors' marketplaces, in full compliance with applicable regulatory requirements and company standards:
    • Product Complaints
    • Quality events (deviations; quality alerts, quality risks)
    • Recalls
    • Temperature excursions
  • Coordination across SANOFI CHC in relation to activities executed by the Distributors in scope:
    • Repackaging/Redressing operations (regular follow-up on all operations performed including coordination of certification by the original manufacturing site Qualified Person, regular review/update or corresponding Quality agreements)
    • Support random Quality Control testing by local Health Authorities (supply of reference standards, documentation …)
  • Contribution to the assessment of the CHC Product Quality Reviews (PQRs) by the Marketing Authorization Holder (MAH) in the “Distributors Business Model countries” where SANOFI CHC is MAH, in compliance with applicable requirements:
    • Collection of required data specific to each market
    • Provide conclusions of the PQR evaluation to the MAH for its validation
    • Make PQRs available to distributor for evaluation when distributor is MAH
  • Management of Changes impacting the assigned Distributors. For change requests coming from distributors: follow-up of the implementation.
  • Quality management of assigned Distributors
    • Qualification/Quality assessment of Distributors
    • Regular operational meetings with Distributors, Annual Quality Review
    • Training of Distributors personnel to SANOFI CHC processes & ways of working
    • Annual review/update of Quality Agreements with Distributors, as well as with manufacturing sites and MAH for distributors markets
    • Analysis of the outcomes of the audits of the Distributors, ensure that efficient action plans are defined, implemented and followed-up until closure by the auditors
    • Annual evaluation of Distributors Quality performance
    • Support to Distributors in case of inspection by local Heath Authorities (GDP, GMP)
    • Qualification of manufacturing sites by distributors when MAHs
  • Contribution to CHC Global Quality Projects with impact on Distributors (as needed)

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