3rd Party Quality Operations Manager - ExM 1

 

Product management

• Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality.
• Taking actions needed to assure the products quality and compliance. In addition, initiation, coordination, supervision and functional assessment of activities that are carried out by the relevant expert team for this purpose

Supplier Management

• Act as an internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products. Coordination and controlling of all GMP relevant documents with regard to manufacturing process, quality control and quality assurance.
• Support of the Quality Relationship Manager

 Change Management

• Support/ perform the initiation, coordination and evaluation of new product introductions and product changes (change control) and check for completeness the variation packages/documentation necessary for submission to ensure projects success.

Supplier Qualification (on-going)

• Maintains the regulatory compliance of suppliers with EMA authorities by maintaining up to date the List of Approved Vendors for the allocated vendors and performing all associated activities (related to audits, inspections and QTA’s)
• Support the execution of the QA Due Diligence of New and Existing Contract Manufacturer
• Review and Authorize Master Documents (CoA, Manufacturing Description, Manufacturing Instruction, Master Batch Record, Stability Schedules, Analytical Methods, Specifications etc.) in order to assure regulatory compliance on the supplier’s level.

Quality Technical Agreements

• Support the negotiation, preparation and approval of new QTA’s ensuring the compliance with the applicable Teva standards and regulations.
• Perform/ support periodic reviews of the QTA’s and amending previously existing Quality Agreements on an as needed basis

 Technical Visits/Audits

• Support preparation and execution of regular audits/ technical visits to the entrusted vendors.
• Support inspection readiness at the relevant suppliers as per alignment with ExM and Global Quality
• Support Inspection readiness at the site of employment

Review of Product Quality Reports (PQRs)

• Support the initiation & Oversight on PQRs for medicinal products manufactured by 3rd parties compiled by the vendor & Global Quality Services (PQR team) in order to insure that all products in her/his portfolio are included in the PQR planning.

Deviations and Critical Quality Incidents:

• Support the necessary investigation and closure of deviations
• Support in all activities related to management of Critical Quality Issues

Miscellaneous

• Support the creation and maintenance of standard operational procedures according to Teva standards and in line with applicable legislation. Follow the SOPs relevant for her/his activities.
• Perform other duties as assigned and agreed.