AS&T Hub Team Coordinator

Summary

-This position is responsible for the manages Quality aspects&projects within area of responsibility. He/she supports analytical investigations, validation, remediation, transfer and implementation of analytical methods. He/she works cross-functionally with MSandT(Manufacturing Sciences and Technology), Development and the Novartis networks to ensure the success of assigned projects.

About the Role

Major accountabilities:

• Manage Quality AS&T Hub aspects & projects within area of responsibility

• Ensure and supports overall GxP conformity & Compliance with the Novartis Quality Management Systems

• Oversight of all Analytical Science & Technology Hub activities including method development, method validation and method transfer, ensures compliance with cGxP, incl. data integrity & eCompliance

• Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements

• Resource and capacity (people and equipment) planning and workload management

• Coordination and leadership of departmental operational activities

• Line responsibility & daily walkthrough

• Lead OpEx Projects

• Investigation of Deviation, OOx, Complaints

• Define and implement CAPAs

• Track team metrics and ensure KQI/KPI meet requirements

• SOP review & revision

Minimum Requirements:

University degree in Pharmacy, Chemical Engineering or Chemistry

• Minimum 5 years of Analytical Laboratory experience with equipments e.g. HPLC, GC, UV/Vis and Wet Chemistry preferably at a pharmaceutical company

• Proven experience in team leadership and performance management

• Knowledge of cGMP& cGLP and basic SAP

• Ability to work in a fast-paced changing environment

• Team working and customer oriented mindset

• Good analytical thinking skills

• Strong interpersonal written and verbal communication skills

• Good knowledge of MS Office applications

• Good command of English is required

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Operations

Business Unit
Innovative Medicines

Location
Turkey

Site
İstanbul Kurtköy

Company / Legal Entity
TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.

Functional Area
Quality

Job Type
Full time

Employment Type
Regular

Shift Work
No