Trd Quality Process

4 giorni fa

Montà, Italia Novartis A tempo pieno

**Summary**:
TRD Quality Process & Engineering Manager will collaborate with RLT Engineering organization for RLT TRD, to establish, maintain and improve the engineering processes with respect to buildings, equipment, utilities and energy.
This role includes oversight of operational and validation activities and continuous process improvements.
**About the Role**:
**Key responsibilities**:
- Support a discipline and/or provide a service individually or within a team of associates.
May provide functional expertise to Line Unit and other QA Units in area of responsibility.
- Write review, decide on approval and release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
- Manage project related activities (e.g.
TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
- Support Project management functions as a project team member
- Provide support to TRD line functions in GMP related topics as per area of responsibility
- Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.
).
- Ensures manufacturing processes, facility, equipment and software are properly qualified and validated for GMP use.
- Generate and maintain VMP to ensure all facility, equipment, process, utilities, analytical methods, cleaning and computerized systems are qualified in compliance with regulations, standards, and specifically with GMP.
- Oversight of external parties responsible for maintenance and qualification/ re-qualification of pilot plant areas and equipment.
- Review and approve URS, DQ, IQ, OQ and PQ documentation.
- Drive continuous quality improvement program for aseptic manufacturing operations and partner with production, engineering and supply chain teams to implement/optimizes to improve efficiency (right the first time) and monitor/escalate as needed.
- Ensure review, decision and approval of all GMP deliverables.
- Approval of the whole set of documents in the area of analytical instruments and production equipment qualification and operation.
- Approval of equipment periodic reviews.
- Approval of Change Controls (CCP)
- Review/Approval of Deviations, Actions, CAPAs and Quality Events.
- Support for inspections preparation.
- Approval in document management systems
- Review of SOPs in ESOPS D2
**Essential Requirements**
- Bachelor Degree
- Fluent in Italian and English
- Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
Scientific, technical and regulatory knowledge in a specific area.
- Basic knowledge of drug development.
- Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
Good organizational skills.
**You will receive**: You can find everything you need to know about our benefits and rewards in the Novartis Life
**Commitment to Diversity and Inclusion**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Division
Development
Business Unit
Innovative Medicines
Location
Italy
Site
Ivrea
Company / Legal Entity
IT58 (FCRS = IT058) AAA Italy Srl.
Functional Area
Quality
Job Type
Full time
Employment Type
Regular
Shift Work
No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  • Quality Process

    1 giorno fa

    Montà, Italia Novartis A tempo pieno

    394643BR**Quality Process & Engineering Manager**:Italy**About the role**Ivrea, Italy (Hybrid) #LI HybridWe are seeking a Quality Process & Engineering Manager to establish, maintain and improve the engineering processes with respect to buildings, equipment, utilities and energy.This role includes oversight of operational and validation activities and...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Novartis Farmacéutica A tempo pieno

    To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Healthcare Businesswomen’S Association A tempo pieno

    Job Description Summary To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Healthcare Businesswomen’S Association A tempo pieno

    Job Description Summary To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Healthcare Businesswomen’S Association A tempo pieno

    Job Description Summary To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Novartis A tempo pieno

    **Summary**:To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Novartis Farmacéutica A tempo pieno

    To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Novartis Farmacéutica A tempo pieno

    To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon objectives and...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Novartis A tempo pieno

    Summary To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Novartis A tempo pieno

    Summary To lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon...

  • Trd Pilot Plant Quality Control Head

    3 settimane fa

    Montà, Italia Novartis A tempo pieno

    SummaryTo lead the Ivrea TRD RLT Pilot plant Quality Control (QC) team by developing and executing strategic plans, providing direction for organizational structure, GMP and safety strategy, lean and continuous improvement initiatives, and people training and development. The QC Head is responsible for ensuring that the lab unit meets all agreed-upon...

  • Trd Formulation Project Leader

    4 giorni fa

    Montà, Italia Novartis A tempo pieno

    The TRD Formulation Project Leader creates and drives with scientific & technological excellence the formulation development and manufacturing of inhalation, parenteral, topical and ophthalmic dosage forms in close collaboration with operations, analytics, particle engeeniring and biopharmaceutical experts, QA and the project DPPL.Major activities are:...

  • Plant Quality Control

    3 settimane fa

    Montà, Italia Dana Incorporated A tempo pieno

    Dana is a global leader in the supply of highly engineered driveline, sealing, and thermal-management technologies that improve the efficiency and performance of vehicles with both conventional and alternative-energy powertrains. Serving three primary markets - passenger vehicle, commercial truck, and off-highway equipment - Dana provides the world's...

  • Associate Director, It Site Business Partner For Technical R&D

    1 mese fa

    Montà, Italia Novartis Farmacéutica A tempo pieno

    Associate Director, IT Site Business Partner for Technical R&DJob ID REQ-10021921ItalySummaryThe IT Site Business Partner for Technical Research and Development to be based in Ivrea Italy captures IT demand, collaborates with IT functions, and supports the implementation of digital strategies at the Ivrea site. The role contributes to the Product Roadmap,...

  • Quality Process Control Specialist

    4 giorni fa

    Montà, Italia Buscojobs IT C2 A tempo pieno

    DESCRIZIONEImportante Azienda seleziona per il plant di Michelin di Cuneo un/aQuality Process Control SpecialistTi occuperai di:Assicurare l'ottenimento e la performance di Progresso della qualità nella propria area di responsabilità;Supportare nella realizzazione del piano progresso ed il follow-up dei risultati, contribuendo alla messa a terra dei...

  • Trd Formulation Scientist

    4 giorni fa

    Montà, Italia Novartis A tempo pieno

    **Your key responsibilities**:Your responsibilities include, but are not limited to:- Plan together with FPL (formulation project leader) and perform formulation development, characterization studies and experiments.- Ensure objective and deliverables are well understood and deliver high level of lab work.- Ensure consumables, excipients, equipment...

  • Associate Director, It Site Business Partner For Technical R&D

    4 settimane fa

    Montà, Italia Novartis A tempo pieno

    Summary The IT Site Business Partner for Technical Research and Development to be based in Ivrea, Italy captures IT demand, collaborates with IT functions, and supports the implementation of digital strategies at the Ivrea site. The role contributes to the Product Roadmap, supports global rollouts and change management, and works with the Italy Ivrea DDIT...

  • Associate Director, It Site Business Partner For Technical R&D

    2 mesi fa

    Montà, Italia Novartis A tempo pieno

    Summary The IT Site Business Partner for Technical Research and Development to be based in Ivrea, Italy captures IT demand, collaborates with IT functions, and supports the implementation of digital strategies at the Ivrea site. The role contributes to the Product Roadmap, supports global rollouts and change management, and works with the Italy Ivrea DDIT...

  • Associate Director, It Site Business Partner For Technical R&D

    4 mesi fa

    Montà, Italia Novartis A tempo pieno

    Summary The IT Site Business Partner for Technical Research and Development to be based in Ivrea, Italy captures IT demand, collaborates with IT functions, and supports the implementation of digital strategies at the Ivrea site. The role contributes to the Product Roadmap, supports global rollouts and change management, and works with the Italy Ivrea DDIT...

  • Rlt Analytical Expert

    3 mesi fa

    Montà, Italia Novartis Farmacéutica A tempo pieno

    Location: Ivrea, ItalyRole Purpose:Design and plan scientific experiments as well as report and interpret results/outcome in line with the overall TRD RLT project strategy for RLT Drug Substance(s) and Drug Product(s) in development. Ensure project knowledge generation and preparation/timely delivery of supplies with high quality and state of the art...