· Lead and manage the QA department to ensure robust implementation of Quality Management Systems (QMS), including Change Control, Product Quality Review, and Risk Management.
· Serve as the Authorized Person for final product release, ensuring compliance with GMP and timely delivery aligned with production schedules.
· Oversee and verify that all required validations, QC testing, batch record reviews, deviation management, and regulatory requirements are met prior to batch release.
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A minimum of 5 years' experience in Strategy, Business Analyst or Consulting is highly valued.
Proficiency in the use of SQL is a MUST- you should be comfortable independently writing complex queries to extract and analyze large datasets
A proven ability to interpret data, identify gaps within current processes, and devise and implement strategic improvement plans are critical requisites for this role
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Assist the Head of Quality Department and his/her assigned nominees) on the following (but not limited to) matters:-
- Responsible in the operational techniques and activities used to fulfill the requirements for quality control.
- Conduct quality control activities for the products of the Company in accordance to the SOP i.e. colony-forming unit (CFU) assay, flow cytometry analysis, etc.
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Report audit outcomes and trends to management for governance and decision-making.
Conduct QA/QC technical compliance reviews, ensuring timely updates to procedures and quality documentation.
Perform quality performance analysis and reporting, including customer satisfaction metrics, quality incident rates, and competency gap assessments.
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Review the quality of all materials at the site, ensure compliance with all project specifications and quality, and collaborate with the department for all material procurement and quality materials.
Supervise the effective implementation of all test and inspection schedules, ensure adherence to all procedures, and coordinate with various teams to perform quality audits on processes.
Assist with employees to ensure knowledge of all quality standards, ensure compliance to all quality manuals and procedures, and collaborate with contractors and suppliers to maintain the quality of all systems.
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Ascertain all inspection are performed on all completed work and that proper inspection records, reports and forms are properly executed prior to release the parts.
Manage and control the calibration of M&TE
Responsible for leading day to day Quality Control in production ensuring that production quality metrics are met
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Ascertain all inspection are performed on all completed work and that proper inspection records, reports and forms are properly executed prior to release the parts.
Manage and control the calibration of M&TE
Responsible for leading day to day Quality Control in production ensuring that production quality metrics are met
...