Key Areas of accountability / responsibility
The job of Product Quality Leader will include a selection of the responsibilities mentioned below :
Responsible for final disposition to customers of cell banks and bulk pharmaceutical products and for managing all activities to enable this disposition in an efficient and cGMP compliant way according the agreements made with the project manager, the client and according to regulatory expectations.
Proposes and implements improvements related to quality and compliance.
Advise to project organization and customers on all relevant cGMP matters and assure appropriate cGMP level of project activities.
Serves as quality advisor for investigations and recommends actions to ensure continued compliance and avoiding recurrence.
Reviews and approves cGMP documents associated to the product in compliance with local and corporate SOPs and applicable legislation.
Approves investigations assuring that they are complete, accurate, technically justified with the required documented evidence including risk assessment.
Review and approval of Process and Product Validation and Qualification Reports.
Review and approval of Testing Validation and Qualification Reports.
Perform the investigation of Product Complaints and Recalls.
Evaluates and approves Changes associated with the product.
Plan, perform and monitor in collaboration with the project manager QA activities within the project to ensure results are according the agreement and regulatory expectations.
Provides assistance and guidance with regard to the Quality Systems to other departments. Proposes and implements improvements to these systems.
Support Regulatory Area for update of Regulatory Status of Thermo Fisher Scientific Groningen. Informs department about changes in regulatory guidelines.
Support Regulatory Area and customers in regulatory requirements related to the submission and maintenance of their product applications and approved licenses.
Execution of internal audits.