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.
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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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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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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