Senior Process Expert / Manufacturing Science and Technology

Job Description Summary

The purpose of the Senior Process Expert (Manufacturing Science and Technology) is to work collaboratively with process experts and the multifunctional operations teams in Steriles/large molecules platform and take ownership of the deviation management for the site.

You shall actively participate in investigations of Deviations/Complaints/OOXs by interacting with Cross Functional Teams (CFT) and implementation of Corrective and Preventive Actions (CAPA), Effectiveness Check (EC), Risk assessment and Quality management.

In this position you will report to the Project Lead based in Austria.

Job Description

Location: Istanbul Kurtköy, Turkey #LI-Hybrid

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key Responsibilities: 

• Using structured RCA (Root Cause Analysis) methodologies such as impact assessment, Fish bone diagram, 5 whys, Timeline & process mapping for investigation of deviations
• Handling Investigations and Deviations related to Process (Upstream / Downstream), Product & Equipment
• Understanding of core manufacturing unit operations such as sampling, monitoring, and continuous process support
• Handling procedural requirements for HA audits
• Responsible for offering technical and scientific expertise to address process-specific matters, ensuring compliance with cGMPs, SOPs (Standard Operating Procedures), and relevant guidelines and functional standards (such as HSE (Health, Safety and Environment) and NOSSCE)
• Handling internal and health authority audits and inspections
• Ensuring overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Essential Requirements:

• Bachelor’s degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Master´s degree is a plus
• Min 8 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility
• Minimum 5 years of experience with deviation management and investigation
• Knowledge of risk assessment and risk management programs
• Fluent English, German is a plus

Desirable Requirements:

• Good communication, presentation and interpersonal skills
• Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistica etc.)

Benefits and Rewards:

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook

Commitment to Diversity & Inclusion:

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

Skills Desired

Assembly Language, Continual Improvement Process, Efficiency, General Hse Knowledge , Good Documentation Practice, Change Control, Chemical Engineering, Chemistry, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Process Control, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure), Team Work, Technology Transfer, Web Methods Flow

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