Ensures that operations in relation to imported or manufactured raw materials and bulk pharmaceutical products comply with national and/or international regulations and guidelines (cGMP) as well as quality policies.
Ensures that the products are in compliance with the corresponding marketing files.
Makes decisions on the release, rejection or rework of these products.
Proactively assists operations in identifying, developing and implementing quality and operational excellence improvements in response to business, technical and regulatory requirements.
As a QA/QP, your primary responsibilities will be as follows:
Release and certification of the above mentioned product lots, management of legal samples.
Management of quality deviations, investigations, CAPAs, market/customer complaints, recalls, temporary and permanent change controls.
Drafting, review and approval of Product Quality Reviews.
Writing, review and approval of procedures related to the field of activities.
Follow-up and QA support to projects defined by the QA management, and more specifically in relation with release and dry form production activities.
Carrying out internal audits, participation in customer audits and inspections in relation to the field of activity.