To ensure Duopharma Manufacturing (Bangi) premises and its operation complies with current GMP (cGMP & GDP) guidelines as defined by local drug control authority.
Maintenance of bulk BOM in SAP system and submit material master maintenance for system update.
Documentation control- ensure proper control and maintenance of all QA documentation.
Product release: review & approve all information in the BMRs and ensure COAs are accurate and results are within specifications before final release.
To carry out investigation on product complaint NCR, DEV, CAPA and ensure closure.
To check and approve artworks for packaging materials.
Perform external & internal audits and recommend appropriate corrective actions to ensure GMP, ISO 9001 and GDPMD compliance.
*. Coordinate and prepare product quality review report as per planned schedule.
Minimum Working Experience
Second Class Upper
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