Validation Expert...
1 giorno fa
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 DescriptionMajor 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)#J-*****-Ljbffr
-
Validation Expert
7 giorni fa
Montà, Italia Novartis Pharma Schweiz A tempo pienoJoin to apply for theValidation Expertrole atNovartis Pharma SchweizThe 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...
-
Validation Expert
1 settimana fa
Montà, Italia Novartis Italia A tempo pienoThe 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.About The RoleSupport site validation planning by writing and...
-
Validation Expert
1 settimana fa
Montà, Italia Novartis Italia A tempo pienoSummaryThe 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.About The RoleMajor accountabilitiesSupport site validation...
-
Validation Expert
5 giorni fa
Montà, Italia Healthcare Businesswomen’S Association A tempo pienoJob Description SummaryThe 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 DescriptionMajor accountabilitiesSupport...
-
Validation Expert — Gmp Process
1 settimana fa
Montà, Italia Jobs For Humanity A tempo pienoA prominent health organization in Saluggia, Italy seeks a Validation Expert to manage packaging and cleaning validation activities in compliance with cGMP standards.The ideal candidate holds a scientific degree and has experience in a sterile GMP environment.Key responsibilities include maintaining master validation plans, reviewing validation protocols,...
-
Senior Validation Specialist – Process
1 settimana fa
Montà, Italia Novartis Italia A tempo pienoA leading multinational pharmaceutical company in Ivrea seeks a Validation Expert responsible for executing compliance validation activities in a sterile GMP environment.The ideal candidate will manage process validation and collaborate for technical transfers with a focus on quality risk management.A scientific degree and experience in a similar role are...
-
Senior Validation Specialist – Process
3 giorni fa
Montà, Italia Novartis Italia A tempo pienoA prominent pharmaceutical company in Piemonte is seeking a Validation Expert to oversee validation activities to ensure compliance with cGMP requirements.The role involves writing validation protocols, collaborating with cross-functional teams, and maintaining master plans for processes.Ideal candidates will have a scientific degree and previous experience...
-
Senior Validation Specialist – Gmp Processes
5 giorni fa
Montà, Italia Healthcare Businesswomen’S Association A tempo pienoA leading healthcare organization in Ivrea, Italy, is looking for a Validation Expert to manage process, primary packaging, and cleaning validation activities.The ideal candidate should hold a scientific degree and have prior experience in a sterile GMP environment.The role involves writing and maintaining validation plans, reviewing protocols, and...
-
Pharma Validation Specialist
7 giorni fa
Montà, Italia Novartis Pharma Schweiz A tempo pienoA leading pharmaceutical company in Italy is seeking a Validation Expert to manage process and cleaning validation activities.You will ensure compliance with cGMP requirements and collaborate across functions to analyze and control risks.The ideal candidate should have a scientific degree and previous experience in a sterile GMP environment, along with...
-
Montà, Italia Pqe Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal **** , garantendo una presenza internazionale grazie alle 45 filiali e i **** dipendenti in Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti...
