Quality Compliance Coordinator

390875BR

About the role

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

Position Title

Quality Compliance Coordinator

Role Requirements

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

Job Type

Tam Zamanlı

Country

Türkiye

Work Location

İstanbul

Functional Area

Kalite

Division

Operations

Business Unit

QUALITY

Employment Type

Daimi

Company/Legal Entity

Novartis Turkey

Commitment to Diversity & Inclusion:

Olağanüstü, dahil edici bir çalışma ortamı sunmak ve hizmet verdiğimiz hastalar ile toplulukları temsil eden çeşitli ekip temsilcileri oluşturmaya kendini adamıştır.

Shift Work

Hayır

Early Talent

Hayır