Conduct site inspections and quality verification activities in accordance with approved Inspection & Test Plans (ITP), project specifications, and quality standards.
Coordinate material testing, workmanship inspections, and quality assessments with consultants, laboratories, and project stakeholders.
Verify construction works comply with approved drawings, specifications, method statements, and contractual requirements.
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Product and material inspection: Perform incoming, in-process, and final inspections to check that products and materials meet quality standards and specifications.
Testing: Conduct tests on products and materials to identify defects or deviations.
Documentation: Record inspection results, document any issues found, and update relevant forms or reports.
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Bachelor's Degree or Diploma in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or a related field.
Minimum 1-2 years of experience in pharmaceutical regulatory affairs or product registration. Fresh graduates with relevant internship experience are encourage to apply.
QA Team Management : Oversee the daily management of the GTR QA team ( IPQA , FQA ), including daily work scheduling, implementation of monthly performance appraisals, and management of all staff attendance; also responsible for building a personnel training system and continuously conducting skills training to improve the team's overall business capabilities.
Production control : Supervise and review the first piece confirmation of each work order, material verification for production line changes, and consistency verification of material receipts to ensure that quality risks in the veneer production process are effectively controlled.
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Develop, implement, maintain, and continuously improve the Company's document control system to ensure compliance with internal procedures and applicable quality management standards.
Administer the complete document lifecycle, including document creation, review, approval, issuance, revision, distribution, retrieval, retention, archival, and disposal.
Maintain the Master List of Controlled Documents and ensure document status is accurately reflected at all times.
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Develop, implement, maintain, and continuously improve the Company's document control system to ensure compliance with internal procedures and applicable quality management standards.
Administer the complete document lifecycle, including document creation, review, approval, issuance, revision, distribution, retrieval, retention, archival, and disposal.
Maintain the Master List of Controlled Documents and ensure document status is accurately reflected at all times.
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Prepare, compile, review and submit product registration and variation applications to the relevant regulatory authorities (e.g., NPRA).
Monitor the status of product registrations, renewals, amendments and variations. Ensure all product registrations are maintained in compliance with current regulatory requirements.
Liaise with regulatory authorities regarding product registration matters and respond to queries promptly. Coordinate with internal departments such as R&D, Quality Assurance, Production, Purchasing, Marketing and Sales to obtain required documentation.
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