Development QA Operations Specialist
Novartis 796 recensioni - Siena, Toscana

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A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
Think what's possible.

Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings.
Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information.

Descrizione dell’attività (circa 3-6 tra le più importanti mansioni):
• Maintain and assure an adequate GMP oversight process in TD
o Issuing of Batch production Documents to be used in TD for clinical or preclinical batches
o Review and Approval of Master Batch Production Documents and Master Batch Records for clinical studies prepared by TD
o Review and Approval of Batch Documents for preclinical studies prepared by TD and issue of requested documents
o Management, review and trending of deviation reports and CAPA related to IMPs of TD processes
o Management of OOS related to TD
o Release of Production Areas and Utilities related to TD
o Development and maintenance of SOPs for DevQA activities
o Alarm Monitoring of TD areas
o Review and evaluation of periodical EM trends for the areas of pertinence
o Prepare and update Quality KPIs related to TD processes
o Performs review of PFS
• Support Batch Disposition process for Clinical batches
• Act as reference and support during inspections
• Guarantees assurance of GMP compliance for controlled documents in TD (e.g. SOPs, changes, transfer reports, analytical methods)
o Development and maintenance of SOPs for DevQA activities
o Performs technical review for Change request and subsequent action plans for a correct documentation and implementation
o Performs the activities defined in ATLAS EDMS workflow regarding review/approval and release of controlled documents (doc control) and impacted systems (training, change request, LIMS).
o Guarantees completion of the requirements for implementation of the documents
o Monitors the progress for documents and change request management in order to assure compliance with approved change requests
o Performs evaluation on quality impact and implementation of the change in terms of Batch release
o Approves action plans and final approval for change requests (as delegate)
• Guarantees assurance of GMP compliance for Validation approaches related to equipment qualification, analytical method and cleaning validation activities performed in TD.
o QA Review and approval of Validation protocol and reports for TD
o Issuing of Validation Master Plan, periodic report and GMP requirements for TD
o Management of validation deviation
o Update and monitoring of Validation scheduling
o Archive validation documentation according to Novartis Procedure
Novartis is an Equal Opportunity Employer.
Minimum requirements
• Degree in life science or equivalent with a minimum of 3 – 5 years experience in QA or in a GMP area in the pharmaceutical industry either in technical/process development.
• Good knowledge in use of the MS Office package and a very good knowledge of the English language.
• Good Communication and interpersonal relationship skills.
• Team player, flexible, open and reliable

Informazioni sull'azienda
796 recensioni
Novartis International AG è un'azienda multinazionale svizzera che opera nel settore farmaceutico. Seconda multinazionale farmaceutica al...