As&t Expert

2 weeks ago

Tuas, Singapore Novartis Full time

**Summary**:
This position is responsible for the direction and oversight of the analytical projects. He/she supports analytical investigations, validation, remediation, transfer and implementation of analytical methods. He/she works cross-functionally with QC, MS&T (Manufacturing Sciences and Technology), Manufacturing, Supply Chain and the Novartis networks to ensure the success of assigned projects.

**About the Role**:
**Key Responsibilities**
- Own & Lead projects, often complex in nature; including direct responsibility for leading various teams to successful completion of various projects. Strong ability to manage multiple priorities.
- Own & Lead analytical method transfer / validation / verification and to ensure full compliance of introduced analytical methods to current standards. Responsible for implementation of projects into QC laboratories.
- Work with tech transfer teams to prepare new processes; point of contact for QC/lab operations for external customers. Set-up and coordinate detailed planning and document deliverables as per Master Plan and agreed timelines by working collaboratively within QC and cross-functional teams.
- Direct customer and regulatory agency interaction as required. Involve in regulatory audits in an independent manner. Responsible for analytical validation/transfer topics.
- Lead and approve validation documents (Example: Method Qualification / Validation / Investigation).
- Superior ability to troubleshoot all applicable methods.
- Provide trending and statistical support for periodic reporting, and or decision making
- Support investigations for major and critical discrepancies (OOS, complaints, deviations). Make recommendation for product quality impact assessments and propose CAPA actions.

**Essential requirements**:

- Minimum: BS in Pharmacy, Biotechnology, Chemistry, Microbiology or Chemical Engineering
- Desirable: PhD in Biotechnology, Chemistry, or Chemical Engineering
- 8+ years of related experience. Related experience should be in GMP-regulated industries in Quality Control. Experience in analytical validation/transfer is a plus.
- Must understand FDA/EMA/ICH requirements as well as industry quality systems
- Knowledge and understanding of manufacturing and quality control. Experience in bio-technology/bioprocess/bio manufacturing is highly desirable.
- Strong analytical, planning, execution, interpersonal, communication, negotiation and problem-solving skills
- Strong project management skills
- Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally

Division

Operations

Business Unit

Innovative Medicines

Location

Singapore

Site

Tuas South Avenue

Company / Legal Entity

SG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

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.

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