Kerja Sepenuh Masa, Quality Control Operation (Document Training - Sample Management) di WuXi Biologics - Maukerja

Overview

WuXi Biologics is a leading global Contract Research Development and Manufacturing Organization (CRDMO) specializing in biologics. The Singapore site is a greenfield biopharmaceutical start-up project with large-scale Drug Substance (DS) and Drug Product (DP) manufacturing operations, establishing one of the largest biologics production capacities in Singapore.

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

Responsibilities :

• Responsible for QC daily sample/retention management operation to comply with GMP and data reliability.
• Responsible for QC sample 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 (when required).
• Responsible for drafting QC department documents, quality standards 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, participate in LIR (lab investigation), or lab OOS, and review changes and deviations in other departments involving QC.
• Involve in the development and revision of QC training program. Ensure QC training JC (Job code) modules encompass essential training in basic/advanced cGMP training, applicable functional techniques in associated SOPs, TRAs, AMPs, and OJTs.
• Involve and represent QC in all training related activities for QC department (with QA) and ensure adherence to timely GMP training. Act as QC training coordinator for non-GMP training.
• Involve as site Safety Committee member representing QC and tasks as leader for RA related to safety.
• 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.
• 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

Requirement

• Bachelor of Science / Pharmaceutical Science / Chemistry or Biochemistry or equivalent field.
• 6 - 8 years of relevant experience in quality control laboratory or in a GMP environment
• Experience setting ICH based stability studies for therapeutic proteins.
• Strong communication skills, both written and verbal, and outstanding interpersonal skills.
• Srong skills in scientific and technical writing.
• Good software operation skills, intermediate to advanced level in Microsoft Word, Excel, PowerPoint.
• Critical thinking, scientific reasoning and problem-solving skills.
• Ability to use judgment as dictated by complexity of situations.
• Ability to work in a team environment and independently as required