Responsible for qualification of production equipment, premise and critical utilities
Assist in preparing validation / qualification protocols and reports
Assist in investigation and follow up of production issues and deviations
Draft, review, or revise SOP for QA and other departments
Oversee quality control processes, batch release procedures and documentation
Conduct root cause analysis and manage CAPA (corrective and preventive actions) for non-conformances
Collaborate with Production, R&D department and warehouse to ensure quality compliance across departments
Participate in product complaint investigation and ensure proper documentation and resolution
Perform Qualified Personnel duties, including reviewing, verifying, and signing off on testing / analytical reports and batch manufacturing documents. Release or reject materials for production and finished product sales, as delegated by the Head of Department
Responsible for final release of finished product in the absence of Quality Manager
To ensure that only passed and approved finished products can be released by issuing the "Approved Sticker" on the finished product
To control supplier performance periodically for evaluation purposes
Responsible for JKKP inspection preparation and audit
Performs tasks as per instructed by superior whenever required
Requirements
Bachelor's Degree / Diploma in Food Technology / Nutrition / Science / Biologist / Chemistry / Pharmaceutical, with a minimum of 3 years in the related field is required for this position (Experience in the Pharmaceutical industry / GMP facility is a requirement)
Understanding of Qualification & Validation processes is an added advantage
Required languages : English, Malay, Mandarin to effectively communicate with Mandarin-speaking clients.
Able to work independently, multi-task and collaborate well with other team-members
Good understanding of GMP and good analytical skills and experience in QC laboratory
Experience in training delivery and quality assurance is preferred
Possess a positive attitude, self-motivated and self-disciplined
Well-versed in documentation handling
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Quality Assurance Executive • Ipoh, Perak, Malaysia