QA of QC engineer.

Your role :

As a member of the Quality Operations team, you will be the Quality Assurance (QA) expert to ensure the compliance of laboratory activities.

As part of the team, you will work in close contact with Quality Control (QC) teams by :

· being one of the QA referents for the operational activities of the QC lab

· Ensure laboratory compliance with Good Laboratory Practices and internal procedures by maintaining a presence in the field

· Evaluating and closing deviations, supporting the related investigation, and identifying recurrences

· Assisting in the definition of corrective and preventive actions (CAPA),

· Reviewing and approving periodic process trend reports as part of the Continued Process Verification process, quality risk analyses, cGMP documentation related to lab activities (procedures, specifications, reports, process control strategies, etc.)

· Reviewing, approving and following the internal and/or multi-site Change Control Propososals (CPP) and ensuring their correct implementation

You will also be responsible to :

· QA Oversight on QC activities: apply and keep up to date the QC laboratory's analysis review strategy for products, the environment and utilities and periodically review of these analyses

· write the raw materials quality chapter of the product quality review (APR)

· approve the acceptance limits of the intermediate and final products (DS), the process gases and purified waters in the LIMS system

· provide the initial and periodic training on cGMPs of QA and QC personnel, and participate in the development of training modules

· participate in authority inspections, internal and corporate audits, and customer audits