Quality Process

6 mesi fa

Colleretto Giacosa, Italia Novartis A tempo pieno

394643BR

**Quality Process & Engineering Manager**:
Italy

**About the role**

Ivrea, Italy (Hybrid) #LI Hybrid
We 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 continuous process improvements.
This role will work directly with the Technical Research and Development (TRD) QA team and reports to the TRD Quality Head.
**Key Responsibilities**:

- Writing reviews/deciding 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.
- Managing 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.
- Supporting Project management functions as a project team member.
- Providing support to TRD line functions in GMP related topics as per area of responsibility.
- Complying with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

**Essential Requirements**:

- Degree in relevant field, or relevant business experience.
- Fluency in English & Italian (both written and oral).
- Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
- Scientific, technical and regulatory knowledge.
- Basic knowledge of drug development.
- Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
- Good organizational skills.

**Commitment to Diversity & 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**

QA GDD

**Work Location**

Colleretto Giacosa

**Company/Legal Entity**

AAA Italy Srl.

**Functional Area**

Quality

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

  • Process Expert

    6 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    393568BR **Process Expert**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear...

  • Process Expert

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    386061BR **Process Expert**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear...

  • Analytical Science

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    The AS&T Lead leads the Site’s AS&T organization, which is responsible to maintain and improve the scientific oversight of the Quality Control processes and technical changes. Ensure the timely execution of AS&T activities in compliance with cGMP legal and regulatory requirements and with Novartis Corporate Quality Manual and Policies. **Your key...

  • Product Expert

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    387159BR **Product Expert**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear...

  • Rlt Analytical Expert

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    392016BR **RLT Analytical Expert (M/F/d)**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear...

  • Technical Steward

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    The Technical Steward provides the specialist knowledge and expertise, as Subject Matter Expert (SME), of specific pharmaceutical processes or process technologies to the Site (e.g. Technical Steward for aseptically manufactured parenteral prodcuts - upstream or downstream, etc). In this role you’ll oversee processes and standards to maintain and improve...

  • Formulation Scientist

    6 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    393706BR **Formulation Scientist - Focus RLT (M/F/d)**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in...

  • Theragnostic Development Team Head

    6 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    **About the Role**: Location: Colleretto Giacosa, Italy Role Purpose: Leads a Theragnostic Team comprising of Drug Product Project Leaders (DPPLs) / Formulation Project Leaders (FPLs) that are members of multiple technical development project teams in a global matrix organization by successfully setting up people and assets to best serve project needs...

  • Trd Formulation Scientist

    6 mesi fa

    Colleretto Giacosa, 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...

  • Rlt Formulation Project Leader

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    392007BR **RLT Formulation Project Leader (M/F/d)**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in...

  • Team Head

    6 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    393709BR **Team Head - Theragnostic Project Management (M/F/d)**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading...

  • Production Manager

    6 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    386628BR **Production Manager**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear...

  • Rlt Drug Product Project Leader

    6 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    392006BR **RLT Drug Product Project Leader (DPPL) (M/F/d)**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation...

  • Study Director

    3 mesi fa

    Colleretto Giacosa, Italia Merck Group A tempo pieno

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...

  • Trd Formulation Project Leader

    6 mesi fa

    Colleretto Giacosa, 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:...

  • Cmc Facilitator

    6 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    386156BR **CMC Facilitator**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear...

  • Commissioning & Qualification Specialist

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    390818BR **Commissioning & Qualification Specialist**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in...

  • Maintenance & Calibration Specialist

    7 mesi fa

    Colleretto Giacosa, Italia Novartis A tempo pieno

    390816BR **Maintenance & Calibration Specialist**: Italy **AAA Statement** **Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear...