QC ENGINEER (Aseptic)

Develop, implement, and uphold quality assurance principles tailored to aseptic machinery, ensuring compliance with GMP and other pharmaceutical industry standards to guarantee the highest product and process quality.

Main Tasks

• Establish, monitor, and execute incoming inspection procedures for aseptic machine components, emphasizing sterile-grade materials and critical parts.
• Develop and maintain inspection checklists specific to aseptic equipment, including sterile packaging, critical seals, valves, and electronic components.
• Monitor and maintain a calibration master list for all precision measurement and testing instruments used in the quality control of aseptic machines, ensuring timely calibration per regulatory standards.
• Participate actively in cross-functional teams focused on problem solving, root cause analysis, and mistake-proofing, particularly addressing issues impacting sterility and aseptic process integrity.
• Interface with internal departments and suppliers on non-conforming materials, leading supplier problem analysis, corrective actions, and follow-up, with a focus on aseptic compliance.
• Assist the QA Manager in planning quality improvements and capital equipment needs related to aseptic machinery production.
• Support the creation, updating, and maintenance of quality documentation including Supplier Non-Conformance Reports (NCRs), procedures, and aseptic-specific compliance records.
• Assist in preparation for and participation in supplier audits and inspections, particularly assessing supplier adherence to pharmaceutical and aseptic standards.
• Maintain and support compliance with ISO 9001 and applicable pharmaceutical regulatory standards (e.g., ISO 13485, GMP).
• Adhere strictly to all company policies, procedures, and aseptic manufacturing cleanroom protocols.
• Manage and input all supplier quality-related activities, including scorecards, NCRs, audit results, and corrective actions.
• Perform additional related duties as assigned by manager.

Information Technology

Competences & Qualifications

Physical requirements

Serac Asia Sdn Bhd is a manufacturer of blowing, filling and capping machines in Malaysia and has been in the country since 1994. For more information please visit our website

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