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
#J-18808-Ljbffr
Quality Assurance Executive • Ipoh, Malaysia