Quality Assurance Officer

2 weeks ago


Metro Manila, Philippines GALDERMA MALAYSIA SDN. BHD. Full time

Responsibilities :

Serves as the GMP and GDP responsible person ensuring that the Quality Management System and the operations comply with the national, regional and international regulation requirementsEnsures that the QA requirements and Galderma standards and procedures are followed throughout the company operationsEnsures all locally and internationally manufactured products meets the required specification set by GaldermaEnsures GMP and GDP requirements are complied by 3rd party manufacturer’s and local service providersEnsures compliance of all packaging materials before and after printingManagement of local quality complaints as per local regulations and proceduresPerforms quality-specific tasks including but not limited to processing product complaints, deviation, CAPA, audits, change control, management reviews and product recallEnsure affiliate 3rd parties are qualified, maintained in approved status and quality agreements established.Implementing and maintaining the QMS to ensure that required SOPs are established.Support principal release of products received inbound.Authorization of product from quarantine to approve status, disposition for trade returns and damaged products.Maintenance, analysis and reporting of Quality KPIsEnsure local repackaging of products is performed in accordance with specifications and required licenses.Conduct induction and refresher training related to QMS for local affiliate staff

 

Requirement :

Bachelor degree and/or above major in life sciences related required or registered pharmacistMinimum 3 – 5 years Quality Assurance experience in pharmaceutical and medical devices and/or cosmetic industry Good knowledge and understanding of GMP and GDP regulations, guidelines and policies governing the healthcare industry (pharmaceutical, cosmetic, medical device)Working experience with regulatory compliance inspectionsGood working relationship with among cross functional teamsExperience working in an international matrix organisationExperience as quality auditor would be beneficialExperience in Quality internal and/or external 3rd party vendor audits

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