Overview

The Quality function is responsible for ensuring that all products meet regulatory requirements, internal quality standards, and patient safety expectations. The team performs laboratory testing and quality assessments throughout the manufacturing process to verify product quality and compliance.

Working Location : Tuas Biomedical Park. Company shuttle bus is provided at various MRT pick-up locations

Job Responsibility

Responsible for QC daily operation and management to comply with GMP, data reliability and occupational safety protection requirements.
Responsible for QC sample, stability and retain sample management, including but not limited to receiving, storage, aliquoting, distributing, tracking and disposing of QC testing sample and reference standards.
Responsible for drafting sampling plan, stability protocol and report.
Responsible for drafting QC department documents, quality standards, analytical method SOPs and application materials, as well as review of relevant documents from other departments involving QC.
Take up LIMS and Cispro specialist roles to support sample, reference standards, retain and stability sample management.
Participate in drafting department OPS management and changes in related analytical methods, may participate in LIR (lab investigation), or lab OOS, and reviewing changes and deviations in other departments involving QC.
Provide laboratory support guidance in any related investigation of production deviations and assist in solving quality problems that arise during technology transfer and daily production (when required).
Ensure that laboratory reagents, consumables and related test solutions are managed and stocked sufficiently (without impacting testing TAT) as required.
Participate in clients audits, regulatory audits and internal and external inspections. Ensure department compliance metrics are well controlled to adhere to the QA Quality council and Quality Management review metrics.
Execute budget planning directions in terms of CAPEX and OPEX expenditure for the department as part of company-wide cost control policy.
Any other duties assigned by the supervisor (when applicable).

Other requirements

Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
8-10 years of relevant experience Quality Control or related field or equivalent experience.
Strong communication skills, both written and verbal, and outstanding interpersonal skills.
Strong skills in scientific and technical writing.
Good software operation skill, intermediate to advanced level in Microsoft Word, Excel, PowerPoint.
Critical thinking, scientific reasoning and problem-solving skills.
Experience in quality control laboratory or in a GMP environment.
Experience setting ICH based stability studies for therapeutic proteins.
Familiar with statistical tools for stability data interpretation and setting expiration date based on stability data and guidance.
Ability to use judgment as dictated by complexity of situations.
Ability to work in a team environment and independently as required

Quality Control Operation Principal Scientist