Senior Chemist 1 - Singapore - Novartis

Novartis

Verified Company

Singapore

2 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

Senior Chemist - Physical Chemistry
Location - Singapore #LI Hybrid

About the Role:

Establish and maintain testing of drug substance release and stability testing including testing of intermediates in process control samples in accordance with written testing SOP's and in accordance with written testing SOP's and local/international regulations.

Key Responsibilities:

Deliver accurate and timely lab test results and solutions to ensure full cGMPcompliance of IPC/DS (In Process control/ Drug substances) shift team.
Provides technical support to run and validate necessary test methods on lab equipment and resolve issues in day to day lab operations including troubleshooting of lab equipment and processes and liaising with manufacturing teams.
Leads in developing method transfer/validation protocols, lab equipment qualification and improvement project
Act as SME (Subject Matter Experts) to train and guide site personnel to perform new methods and instrumentation, other lab related areas and audit preparation.
Carry out investigations and establish root cause and prepare report findings according to global and local standards and requirements.
Monitoring and optimization of work flows and methods/procedures, drug substance control, method controls and reference's and performs trending of ongoing in process control data to pursue an ongoing quality assurance program.
Reviews all lab related QC documents to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs.
Recommend and execute improvement of existing processes or systems to deliver set KPIs.
Able to support rotating shift hours (Day/night)

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._

Minimum requirements

Essential Requirements:

7+ years industry experience, preferably in a cGMP environment.
Related experience should be in GMPregulated industries in Quality Control.
Must have a working knowledge of FDA and exUSA regulatory requirements as well as industry quality management tools, standard, and quality systems.
Must have an understanding of pharmaceutical industry trends and practices.
Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.

Desirable Requirements:

MSc or BS in Pharmacy, Biotechnology, or Chemistry

Division
Operations

Business Unit

QUALITY

Country
Singapore

Work Location
Singapore

Company/Legal Entity

NOV SINGAPORE PHARMA MANUFG

Functional Area
Quality

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No