Turkey Job Openings

Novartis

Quality Compliance Coordinator

Kurtköy

FULL TIME

October 17, 2024

Summary

Manage cost effective Gx P Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant Gx P, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators)
Performs preparation and management of external and corporate audits and Health Authority inspections.
Preperation PQR reports
Ensure Data Integrity Check of Computerized Systems
Follow implementation of the global procedures

About the Role

Major accountabilities:

To ensure that GMP requirements, Novartis policies and ISO 9001 "Quality Management System" requirements are fully implemented & followed throughout the site
To create and maintain related SOPs up to date
To manage the ESOPs and Condor system as site key user and coordinate all individuals.
Follow up and report Quality KQIs
Quality Assurance Approval Role for Deviation, CAPA , QE and OPVR
APQR Sytem Owner and site spoc
Preperation PQR reports (including Change Requests, Medical and Technical Complaint, Advers Events, Effectiveness of CAPAs, Product Performance, Deviations, OOS Results, Release and Stability Performance of Product, Validation Studies, Recall, Manufacturing Volume etc.)
GMP Document Archive Responsible-IGM/GRRS Responsible
To support Excel Validation Protocol and Report Approval and to support QA for Engineering
To ensure Data Integrity Check of Computerized Systems
To support team during preparation for the quality/GMP Inspections performed by 3rd parties, Health Authorities and Novartis Global Quality, prepare the CAPA plan after the audit/investigation report is sent and ensure all CAPAs are completed on time and effectively
Prepare desktop audit reports
Support Global Escalation Management in Site level
Follow implementation of the Site Quality Plan

Minimum Requirements:

University degree in Pharmaceuticals, Chemical Engineering or 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

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

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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