Executive -technology Transfer

2 months ago

Navi Mumbai, India Novartis Full time

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.
POSITION PURPOSE:
Responsible for technology transfer, Post Approval Changes and Validation activities at site.

YOUR KEY RESPONSIBILITIES:
Your responsibilities include, but are not limited to:

- GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. Completion of all trainings assigned to role. Ensure integrity of data at workplace. Ensure Good Documentation practices at workplace.
- Technology Transfer and validation

1. Shop Floor Execution and Monitoring of Scale up/ Validation/Exhibit/Placebo Batches of SDC Transfer Projects and Site Transfer Projects.
2. Preparation of Manufacturing and Packaging Documents for Execution of Scale up/ Validation/ Placebo Batches.
3. Preparation and review of Technical Documents like Intended & Registration MFR, MPR, BMR, BPR, and Scale up protocol & Report & other technical documents.
4. Providing Invoicing Data of Scale up, Placebo, Dossier and Exhibit Batches of SDC Transfer Projects & Site Transfer Project to Finance.
5. Ensure efficient inter and intra‑ departmental Communications as Appropriate.
6. HSE assessments with Site HSEO for new molecule.
7. Review of Executed BMR of Dossier and Exhibit batches.
8. Compilation of data from executed BMR in Transfer Acceptance sheet.
9. To follow GMP & regulatory requirement with respect to technical documentation.
10. Technical assessment for development & site transfer product for their feasibility. Preparation and review of process, cleaning validation protocol and report, hold time study protocol & report.. Ensure that all relevant technical information and documentation for validation is available.
- Novartis manufacturing Manual:
1. Support implementation of Novartis Manufacturing Manual.
- Launch and Transfer:
1. 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.
2. Participate in pre-validation activities and risk assessments to ensure the success of commercial process validation.
3. Ensure that project tracking documentation/tools are up-dated according to plan.
4. Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report)
5. Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate)
6. Contribute to inspection (Pre Approval Inspection PAI) readiness.
7. Ensure site readiness for campaign start-up.
8. Establishes local procedures & templates for technical transfer.
- Manufacturing Excellence:
1. Contribute to process improvement and optimization for product transfers.
- Training:
2. Own the training curriculum for own profile.
3. Provide the necessary training & support to new associates joining this team
- Product Remediation/Investigation

1. Support product remediation and investigation activities involving cross functional teams
2. Ensure that technical batches generate sufficient knowledge on product & process (CMA, CQA, and CPP)
- Product Oversight Knowledge

1. Maintain the oversight of the product(s) assigned at the site
2. Maintain the knowledge and the history of the product(s) throughout the entire commercial lifecycle since from transfer date.

**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._

**Minimum requirements**

WHAT YOU’LL BRING TO THE ROLE:

- Academic Qualification : Bachelor of Pharmacy
- About 10 years of experience in Production for highly regulated generic markets out of which 4+ years of experience in Manufacturing Science and Technology function.

COMMITMENT TO DIVERSITY & INCLUSION:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medi

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