Quality Control Operation (Document Training & Sample Management)

About the role

The Quality function at WuXi Biologics' Singapore site ensures that all products meet regulatory requirements, internal quality standards and patient safety expectations, performing laboratory testing and quality assessments throughout manufacturing. This role covers QC daily sample and retention management, document and training coordination, and supports the Quality team at the Tuas Biomedical Park site, where a shuttle bus is provided from various MRT pick-up points.

Key responsibilities

• Manage QC daily samples and retention samples in line with GMP and data reliability, covering receiving, storage, aliquoting, distribution, tracking and disposal of testing samples and reference standards
• Draft sampling plans when required, and draft QC department documents, quality standards and application materials, and review relevant documents from other departments
• Act as LIMS and Cispro specialist for sample, reference standard, retention and stability sample management
• Take part in drafting department operations procedures, lab investigations (LIR) and OOS reviews, and review changes and deviations affecting QC
• Help develop and revise QC training programmes, including cGMP training, and act as QC training coordinator for non-GMP training
• Represent QC on the site Safety Committee and lead RA matters related to safety
• Support investigations of production deviations and quality problems during technology transfer and daily production
• Keep laboratory reagents, consumables and test solutions stocked so that testing turnaround time is not affected
• Help plan CAPEX and OPEX within the company's cost control policy

Required profile

• Bachelor's degree in Pharmaceutical Science, Chemistry, Biochemistry or an equivalent field
• 6-8 years of experience in a quality control laboratory or GMP environment
• Experience setting ICH-based stability studies for therapeutic proteins
• Strong written and verbal communication and interpersonal skills
• Ability to work in a team and independently

Required skills

• Scientific and technical writing
• Intermediate to advanced Microsoft Word, Excel and PowerPoint
• LIMS and Cispro software