Job Scope:

• Provide technical support to QC testing teams on analytical activities including method development, qualification, validation, verification, transfer, and equipment qualification.
• Support analytical method performance monitoring, troubleshooting, and provide QC technical expertise as a subject matter expert (SME).
• Manage QC reagent qualification and stability programs, including monitoring results, trends, and supporting corrective actions.
• Provide technical support for QC computerized systems such as SAP, LES, and laboratory systems, including system updates, troubleshooting, master data changes, and implementation activities.
• Support GMP quality activities including deviation investigations, CAPA, change controls, SOP/document review, and audit readiness.
• Support data integrity, documentation compliance, and regulatory requirements in accordance with cGMP, quality standards, and company procedures.
• Lead/support QC projects, continuous improvement initiatives, knowledge transfer, and training activities within the team.

Requirements:

• Degree in Chemistry, Biology, Life Sciences, or related scientific discipline with relevant QC laboratory experience (pharmaceutical/biologics industry preferred).
• Minimum 2 years of relevant experience for QC Specialist level; candidates with higher experience may be considered for Senior QC Specialist roles.
• Experience in analytical testing activities including method validation, qualification, verification, method transfer, stability studies, and equipment qualification.
• Good understanding of cGMP requirements, QC laboratory practices, and regulatory expectations.
• Familiarity with QC systems and computerized systems such as SAP, LES, laboratory systems, and related master data management activities.
• Experience supporting investigations, deviations, CAPA, change controls, SOP/document review, and audit readiness activities.
• Strong analytical, problem-solving, and communication skills with the ability to work independently and collaborate with cross-functional teams

To find out more about this opportunity, please contact Fiona Koh; fiona.koh@gmprecruit.com

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Fiona Koh | Registration No: R1109239