Validation Expert
3 settimane fa
Join to apply for the Validation Expert role at Novartis 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 exceptions.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.Review Master Batch Records and associated change controls. Confirm revalidation need based on technical changes.Provide 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.Seniority levelEntry levelEmployment typeFull-timeJob functionQuality AssuranceIndustries: Pharmaceutical Manufacturing#J-18808-Ljbffr
-
Validation Expert
4 settimane fa
Saluggia, Italia Novartis Pharma Schweiz A tempo pienoJoin to apply for the Validation Expert role at Novartis Pharma Schweiz 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...
-
Validation Expert
1 settimana fa
Saluggia, Italia Novartis A tempo pieno**About the Role**: Responsible for developing, implementing and managing the site performance qualifications and requalification of existing equipment and cycles as well any new equipment. Responsible for developing, implementing and managing the site process validation, primary packaging validation, process performance qualification, cleaning validation...
-
Validation Expert — GMP Process
3 settimane fa
Saluggia, 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,...
-
Process & Validation Expert
6 giorni fa
Saluggia, Italia Novartis A tempo pieno**About the Role**: Responsible for developing, implementing and managing the site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs. Responsible for...
-
Senior Validation Specialist – Process
4 settimane fa
Saluggia, 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...
-
Pharma Validation Specialist
4 settimane fa
Saluggia, 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...
-
GMP Micro QC
2 settimane fa
Saluggia, Italia Novartis Pharma Schweiz A tempo pienoA leading pharmaceutical company in Italy is seeking a qualified professional to manage and improve analytical methods and ensure compliance with regulatory standards. The ideal candidate will have a degree in Biology, Microbiology, or Biotechnology, along with proven experience in GMP environments. Responsibilities include method validation, equipment...
-
GMP Micro QC
2 settimane fa
Saluggia, Italia Novartis Pharma Schweiz A tempo pienoA leading pharmaceutical company in Italy is seeking a qualified professional to manage and improve analytical methods and ensure compliance with regulatory standards. The ideal candidate will have a degree in Biology, Microbiology, or Biotechnology, along with proven experience in GMP environments. Responsibilities include method validation, equipment...
-
Micro QC
2 settimane fa
saluggia, Italia Novartis Pharma Schweiz A tempo pienoMajor AccountabilitiesResponsible for the development / validation / verification /
-
Micro QC
1 settimana fa
saluggia, Italia Novartis Pharma Schweiz A tempo pienoMajor AccountabilitiesResponsible for the development / validation / verification / transfer / troubleshooting / monitoring of analytical methods.Manage the method lifecycle and periodically monitor the performance.Lead the qualification of new equipment according to Novartis and regulatory standards.Guarantee the compliance with dossiers and relevant...
