Ensures assigned operation adheres to GMP/GDP/GDPMD requirements, standard operating procedures, secondary Repacking Work Instruction (RWI), batch packaging record and the quality standards set.
Review and maintain quality assurance documents and records in compliance with document control procedures and cGMP requirements.
Ensures only current version of RWIs are used as reference by the interested parties.
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Ensures assigned operation adheres to GMP/GDP/GDPMD requirements, standard operating procedures, secondary Repacking Work Instruction (RWI), batch packaging record and the quality standards set.
Review and maintain quality assurance documents and records in compliance with document control procedures and cGMP requirements.
Ensures only current version of RWIs are used as reference by the interested parties.
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Responsible for performing line clearance activities and in-process checks at production.
Responsible for collecting in-process samples, control samples, finished product samples, stability samples, validation samples, hold time study samples, and swab samples.
Ensures assigned operation adheres to GMP/GDP/GDPMD requirements, standard operating procedures, secondary Repacking Work Instruction (RWI), batch packaging record and the quality standards set.
Review and maintain quality assurance documents and records in compliance with document control procedures and cGMP requirements.
Ensures only current version of RWIs are used as reference by the interested parties.
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As the World's No.1 Nitrile Glove manufacturer, Hartalega is currently in the process of recruiting a diverse pool of talented people, across various specialisations and backgrounds. You will enjoy exceptional benefits and incentives, as well as a well-defined path for career success.
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As the World's No.1 Nitrile Glove manufacturer, Hartalega is currently in the process of recruiting a diverse pool of talented people, across various specialisations and backgrounds. You will enjoy exceptional benefits and incentives, as well as a well-defined path for career success.
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Support the QAQC Manager in planning, implementing, and maintaining the company's Integrated Management System (IMS) in accordance with ISO 9001:2015, ISO 14001:2015, and other relevant standards
Develop, review, and update product specifications, testing protocols, and quality assurance procedures
Oversee product quality inspections, testing, and evaluation to ensure compliance with internal standards, customer requirements, and regulatory obligations (including RoHS, SIRIM, etc.)
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Support the QAQC Manager in planning, implementing, and maintaining the company's Integrated Management System (IMS) in accordance with ISO 9001:2015, ISO 14001:2015, and other relevant standards
Develop, review, and update product specifications, testing protocols, and quality assurance procedures
Oversee product quality inspections, testing, and evaluation to ensure compliance with internal standards, customer requirements, and regulatory obligations (including RoHS, SIRIM, etc.)
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Quality Management System & Compliance: Develop, maintain, and improve the QMS in compliance with ISO 9001, GMP, customer requirements, and applicable regulations.
Audits & Quality Documentation: Lead internal audits, support external audits, and ensure quality documents such as SOPs, specifications, checklists, and quality records are properly maintained and updated.
CAPA, RCA & Non-Conformance: Lead investigations of quality issues, non-conformances, and deviations through Root Cause Analysis (RCA), implement CAPA, and monitor corrective action effectiveness.
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