RAQA Specialist - Commercial Hold - Pusignan - Stryker Corporation

Date de publication : 9/26/2019

Résumé de l'offre

Description de l'offre

Ensure the blocking / unblocking of the devices impacted by a Commercial Hold or a PFA in the ERP System upon Legal Manufacturer request

Ensure the products and the customers impacted by a Commercial Hold or a PFA are properly identified

Require products quarantines and product releases relative to PFAs and Commercial Holds

Notify the customers impacted by a PFA and answer to all associated queries

Ensure the final lot reconciliation. Take any appropriate action to solve the discrepancies related to PFA and Commercial Holds with the support of the other involved Departments

Ensure that all PFA and Commercial Holds are communicated to the local business and key stakeholders

Carefully monitor the follow-up of PFAs and Commercial Holds initiated in France up to closure

Provide reporting as appropriate to local management and Legal Manufacturer when required

Implement and maintain local documentation (procedures, working instructions, training support) related to PFA and Commercial Holds in line with Corporate and EU Policies.

Facilitate information flow with Stryker Division regarding technical information and medical assessments

Provide adequate trainings to other departments and any new on board

Prepare regular reports as requested: weekly / monthly reports, support quality management meetings and audits preparation and readiness

Complete and follow up on actions relating to internal processes in accordance with Company targets, procedures, policies and standards.

Active member of EMEA PER team, providing support to colleagues and working towards streamlined, harmonized, best practice PER process across EMEA. 

Work From Home: No

Travel Percentage: None

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