Set up, start, operate, stop, and adjust plastic machining equipment according to approved work instructions, engineering drawings, and production requirements.
Monitor machine performance and make routine adjustments to maintain product quality and production efficiency.
Load raw materials and unload finished parts while ensuring proper handling and traceability.
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Candidates should possess strong skills in Quality Assurance and Quality Management, including developing, implementing, and maintaining quality systems and policies.
Candidates should possess skills in Quality Control, with experience in product inspection, process monitoring, and verification of compliance with specifications and standards.
Candidates should possess skills in Quality Auditing, including internal audits, documentation review, and support for external and certification audits.
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Perform special process activities such as masking, unmasking, spraying, touch-up, packing, and documentation according to work instructions and customer requirements.
Perform part jigging/un-jigging, bonding, masking, paint mixing, packing, housekeeping, and other production activities.
Operate masking and painting processes according to the Special Process Operation Instruction (SPOI).
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Maintain and coordinate the lab technician partnership and training systems.
Provide process improvement support, specialized testing, training, audit systems, analyze data, identify trends, troubleshoot, corrective action and communication regarding processing data, final product and wastewater.
Assess quality parameters and systems including cross checks, raw materials, calibration, maintenance, procedures, food safety, training, auditing and oversight of analytical testing.
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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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Perform QMS audit to vendors within scope of medical device, drug product, cosmetic product and lab, write audit report, and follow-up supplier CAPA.
Work as project leader in Vendor FDA project, supervise vendor to adequately establish and maintain QMS based on 21CFR820 or 21CFR210&211, and support vendor for FDA audit, act as consultant to help vendor establish a better QMS with professional suggestions.
Monitor vendors’ quality management system with proper visiting in key vendor FDA projects, identify their QMS problems under regular review.
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Supporting companywide continuous quality improvement towards absolute zero-defect culture.
Ensures Quality Policy & Quality Objectives and Management Review Processes are in place;
Quality System Management: Implements the performance measurements necessary to effectively evaluate organizational performance and trends in product quality, services, customer satisfaction and the cost of poor quality;
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Manage and oversee the development and implementation of quality assurance procedures, processes and standards to ensure alignment to global DKSH quality policy and local regulatory guidelines
Develop and maintain quality assurance systems, including the development of quality checklists, supporting tools and techniques
Recommend improvement on policies, practices and processes to ensure the attainment of product quality standards
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Provide daily support for Oracle production, enhancement projects and lean initiatives related to Fusion Cloud and Oracle EBS.
Facilitate business and systems analysis discussions and translate findings into clearly defined Business Requirements Document and Functional Design Document.
Work with the development team in reviewing the Technical Design, validating to ensure the development delivers to the design.
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Act as SGS Malaysia’s technical specialist for Gas Chromatography instrumentation and related analytical testing in food, consumer products and chemical laboratory services.
Train internal laboratory teams and build capability in GC operation, sample preparation, method setup, calibration, troubleshooting, result interpretation and technical reporting.
Establish, review and improve standards, procedures, test methods, work instructions, calibration practices, quality control checks and laboratory methodologies.
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