Mirela Pop

Global Quality Auditing Planning and Implementation for pharmaceutical material suppliers. QMS corporate-wise implementation of the electronic data-bases and staff GMP training. Local auditors certification Program. Cross-functional projects with Procurement for auditing subcontracting and customer services activities, with Legal for 3rd parties QAAs conclusions for various materials (APIs, Packaging materials, Laboratory services, Excipients, etc.) and QAAs with the customers for finished products, etc.

Compliance Oversight role for Sandoz’ worldwide internal sites and with shared suppliers for excipients, packaging materials and GMP consumables.

Responsible for scheduling, organizing and performing quality audits of third parties and Sandoz commercial affiliates globally as routine, non-routine, due diligence, prequalification and verification audits, according to the applicable company standards, regulatory requirements and business needs. Expertise: non-sterile API’s and FDF’s, excipients, warehouses, primary packaging, laboratories. Escalate critical observations within the defined time-frame and process flow.

Study and analyse of medicinal products

Bachelors with a double specialization in Biology and Chemistry