Ms&t Lead

2 weeks ago

Jakarta, Indonesia Novartis Full time

4 The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Come join us and by using your mentoring, critical thinking and business partnering skills, you will be instrumental in bringing hope and making an impact for patients.
- We are looking for individual to join our team who have passion to improve and extend people’s lives.**Your Responsibilities**:
Your responsibilities include, but not limited to:
- Ensure robust product stewardship for all products manufactured at the site, and end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle.
- Ensure single point of contact for products within the site and across sites for multi-site products, as far as process technical issues are concerned.
- Safeguard, maintain and develop the scientific information of product processes.
- Ensure the robustness of manufacturing and packaging processes, so that all site products are validated and remain constant state of validation throughout the product lifecycle.
- Oversee and ensure the robustness and capability of manufacturing and packaging processes by monitoring of each product’s Critical Process Parameter (CPP) and Critical Quality Attributes (CQAs) thru a continued process verification program and review of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs).
- Work with technical research and development organization to ensure a robust commercial scale-up of new products.
- Lead technical transfer activities into the site. Ownership and leadership of the site Validation Master Plan and coordinates all related activities.
- Work across Process Units and Functions within the site and in close collaboration with MS&T global team to resolve issues and to ensure process capability.

**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._

**Minimum requirements**

**What you’ll bring to the role**:

- Degree in Pharmaceutical Technology or equivalent experience
- Minimum 10 years’ experience in pharma manufacturing. Additional specialist experience is preferred (e.g. pharmaceutical formulation, process development, manufacturing technology)
- Proven experience driving quality and compliance in an organization
- Strong knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Fundamental understanding of standard pharmaceutical analytical testing
- Fluent in both written and spoken English

**Division**
- Novartis Technical Operations

**Business Unit**
- NTO OPHTHALMOLOGY LOCAL MARKET

**Country**
- Indonesia

**Work Location**
- Jakarta

**Company/Legal Entity**
- PT Novartis Indonesia

**Functional Area**
- Technical Operations

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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