As&t Expert

1 day ago

Tuas, Singapore Novartis Full time

**Summary**:
Responsible for leading the analytical method transfer, method validation, and verification activities, ensuring compliance with cGxP standards for products. Provide technical support to quality control team related to analytics and specifications. Individual contributor role, ensuring the timely implementation of assigned activities.

**About the Role**:
**Key Responsibilities**:

- Lead analytical method transfer, method validation/verification activities, ensuring full compliance of introduced analytical methods to current standards.
- Support onsite investigations related to OOX and deviations.
- Customer management and new product introduction to the site.
- Improvements in Analytical Methods and life cycle management.
- Introduction of new technologies for analytical testing.
- APQR, OPV analytics section authoring, and perform assessments.
- Stability Study Design, Protocol, and report preparation. Awareness of ICH requirements.
- Basic knowledge of Statistical data evaluation and trend assessment.
- Regulatory dossier reviews for analytical methods, method validation, stability, and control of materials.
- Third-party testing lab management
- Track deliverables and provide technical guidance as per company policy.
- Raw material assessment for new product introduction and pharmacopeia compliance evaluation.

**Essential Requirement**
- BS degree with 8+ years of pharmaceutical/biotechnology analytics industry experience
- MS degree with 4+ years of pharmaceutical/biotechnology analytics industry experience
- Working experience in Laboratory environment in the biopharmaceutical analytics/QC/ equivalent industry.
- Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities
- Must have a working knowledge of health authority and regulatory requirements as well as industry quality management tools, standards, and quality systems.

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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