* Logistic QA Specialist – Roche Rosny sous Bois (France) *  Batches release (pharmaceutical products/medical devices/clinical trial) *  Validation/qualification of equipment: isothermal boxes. *  Carrying out the pharmaceutical and administrative treatment/follow-up of returns (management of a team of 3 people)

* Perform Internal/ External audit & Develop corrective action plans to respond to audit findings, and maintain contract vendor Quality Agreements. * Document and maintain quality procedures in compliance with current applicable regulations * Ensures that the quality system is implemented and maintained in accordance with the FDA/EMEA requirements, ISO 9001, ISO 13485. * Review and investigate customer complaints, problems, and questions concerning product quality and respond accordingly. Ensure that customer concerns are promptly transferred into effective activity. * Assure GMP New Employee Formation * Carrying out the pharmaceutical and administrative treatment/follow-up of returns Show less

Oversee Contract Manufacturing Organization (CMO) activity by leading and performing meetings and audits of CMO. Lead or support investigations and deviation reviews of CMO. Review and investigate customer complaints, problems, and issues concerning product quality and respond accordingly. Ensure that customer concerns are promptly transferred into effective activity. Enhance and maintain metrics for vendor performance and compliance. Oversee centralized functions which support internal and external GMP operations, such as QC, Supply Chain, Materials Management, Validation, Informational Services, Process Development. Show less

* Batch Record review and batch release - Ensuring product manufacturing and testing process is reviewed, all exceptions which may result in product non conformities or quality issues and all changes having quality or regulatory impact are appropriately evaluated/managed to enable batch release. Ensure batch release is executed in compliance with regulation and in a timely manner to satisfy business needs. * Cleaning validation, & qualification * Regulatory Compliance/NPI - Leading New Product Introduction and new project such as MES * Relationship with authorities and global Viforpharma functions. * People Management – Leading a department of over 11 people to deliver major responsibilities of the function, ensuring performance reviews, talent management, development and training. * Compliance processes efficiency . * Ensuring departmental compliance to all relevant Quality/H.R./EHS&E policies, procedures and guideline