Senior Quality Compliance Specialist

NOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNL. SAN. VE TİC. A.Ş.

Responsibilities of Senior Quality Compliance Specialist includes but not limited to:  

•        Act as SPOC at Kurtkoy site for activities transferred from ChemOps for compliance, QA and Regulatory CMC related topics
•        Ensure that below activities in scope are inline with Novartis policies, and GxP requirements:

Preparation of declarations; Notifications to customers;Preparation of allergens, residual solvents statements, source documents; Review of CMC Documents; Change Control; Japan Site Accreditation;Pharmacopoeia and Guidelines evaluation; HA questions; Deregistration; APQR; QA oversight activities for Batch Disposition (retest, returns, packaging material);Deviation (Costumer complaints, OOS/OOE ex Stability/Re-test/Re-turns, Special Customer Requests,Technical, Product, Analytical Change Control); Audit and inspection running/support; Escalations (e.g. Shelf life);Preparation of related SOPs and trainings

Minimum Requirements

•       University degree in Pharmaceuticals, Chemical Engineering or Chemistry
•       Minimum 3 years of experience
•       Excellent communication skills in English
•       Good negotiation skills in English
•       Team working and customer oriented mindset
•       Good at conflict management
•       Knowledge of quality management systems such as deviation, complaint handling, change management
•       Knowledge of regulatory systems and CMC processes
•       Good analytical thinking and problem solving skills