Quality Compliance Coordinator İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Responsibilities of Quality Compliance Coordinator 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 Engineeringor Chemistry
- Minimum 4 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
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