Qualifications: Minimum education of Professional Pharmacist, 3 years of experience as APJ QA in the pharmaceutical industry (drug division). Able to operate documentation and quality systems, manage documents effectively, handle reporting, change control, and deviation reports. Understands regulatory compliance such as preparing internal and external audits and is capable of creating CAPA, ensuring the operational standard of CPOB runs well, and able to lead investigations into OOS/OOT. Capable of creating protocols, reports, and reviewing validation & qualification (DO, IQ, OQ, and PQ). Able to evaluate and release products. Able to operate computers (Microsoft Word and Excel). Job Description: Assist APJ QA. Monitor the performance of the quality system and procedures, assess their effectiveness, and drive improvements. Plan, create, and ensure quality assurance procedures comply with the latest Good Manufacturing Practices (CPOB) principles. Evaluate pharmaceutical engineering complaints and collaborate with APJ QA – QA Manager in making decisions and taking actions based on assessment results, working with other departments if necessary. Ensure that applicable analytical methods or testing procedures are established in accordance with the latest regulations/pharmacopeia. Monitor RIP and the management of manufacturing process validation and service systems according to the established procedures. Ensure quality-impacting deviations, including batch deviations, have undergone risk assessment. Ensure the change control system is applied and that changes aimed at improving the quality system have been approved by APJ QA – QA Manager. Ensure changes can be well implemented. Perform final release or rejection of finished drugs to be marketed if APJ QA – QA Manager is unavailable.

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New Product Development Manager & Industrial Manager APAC

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Quality Control Perusahaan Gadai Milik Negara - Yogyakarta

PAID INTERNSHIP QUALITY CONTROL (QC) - PT SETIA KAWAN ABADI