Validation Expert

Job Description Summary

The Validation Expert is responsible for executing and managing process, primary packaging and cleaning validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory exceptions.

Job Description

Major accountabilities

• Support site validation planning by writing and maintaining master plans for processes, cleaning, packaging.
• Support process validation lifecycle activities by ensuring a state of control is maintained through ongoing.
• Author and review process, packaging or cleaning validation protocols & reports, ongoing process and cleaning verification protocols & reports.
• Support execution of validation activities at the shop floor.
• Reviews Master Batch Records and associated change controls. Confirm revalidation need based on technical changes.
• Provides technical expertise (and may facilitate) pre-validation risk assessments using risk management tools.
• Work collaboratively and cross functionally to help ensure that process risks are analyzed, appropriately controlled and appropriately documented.
• Ensure that all Site validation activities are performed and are in line with the current Novartis requirements and cGMP, manage deviations associated with process validation and make recommendations for deviation resolution as well as prevention of reoccurrence.
• Work in close collaboration with development organization (or sending site) for technical transfers and new product launches to ensure that knowledge is transferred, control strategies are appropriate, risks are analyzed and controlled and to ensure that commercial processes are validation ready.
• Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).

Essential requirements

• Scientific Degree (CTF/Pharmacy/Biotechnology/Chemical Engineering or related field).
• Previous experience in a similar role within a sterile GMP environment.
• Knowledge of Quality and IT tools.
• Fluent in Italian and English.

Skills Desired

• Assembly Language
• Change Control
• Chemical Engineering
• Chemistry
• Continual Improvement Process
• Cost Reduction
• Data Analytics
• Electronic Components
• General Hse Knowledge
• Including Gdp
• Knowledge Of Capa
• Knowledge Of Gmp
• Lean Manufacturing
• Manufacturing Process
• Manufacturing Production
• Pharmaceutics
• Process and Cleaning Validation
• Process Control
• Process Engineering
• Risk Management
• Root Cause Analysis (RCA)
• Scheduler
• Six Sigma
• Sop (Standard Operating Procedure)