Analytical Development Chemist — GMP Validation & Innovation

gsk; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

GSK Singapore is seeking an Analytical Tech Transfer professional to ensure testing activities and specifications meet cGMP and regulatory standards. You will support method validation, new measurement technologies, and product introduction, ensuring accurate data to address issues.

The role involves drafting and updating laboratory documents, ensuring compliant change management, and contributing to risk assessments and safety practices within the lab environment.

Qualifications

• Degree in chemistry or related field required.
• Minimum 3 years of analytical experience in the pharmaceutical or regulated industry.
• Knowledge of GMP and regulatory requirements.

Responsibilities

• Draft, compile, review and update laboratory documents such as analytical methods and specifications, method validation/equivalency protocols/reports, local procedures and guidelines relating to GMP and laboratory operations.
• Ensure data supporting resolution of process and method issues are accurate for correct actions.
• Contribute to plans for implementing new/testing technologies and methods for products or cleaning processes.
• Promote a safe lab environment by participating in safety risk assessments and 6S inspections.
• Lead or participate in investigations arising from lab issues and assess impact to recommend CAPA actions.
• Own and support approval and progression of changes impacting product quality, validation, and cGMP compliance; coordinate testing, review changes, and ensure closure.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Problem Solving

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Education

Bachelor's degree in Chemistry or related field

Job description

GSK Singapore is seeking an Analytical Tech Transfer professional to ensure testing activities and specifications meet cGMP and regulatory standards. You will support method validation, new measurement technologies, and product introduction, ensuring accurate data to address issues.

The role involves drafting and updating laboratory documents, ensuring compliant change management, and contributing to risk assessments and safety practices within the lab environment.