Quality Assurance Executive (12-month Contract)

Job Summary: To work closely with various functions such as Regulatory Affairs, Pharmacovigilance, Supply Chain, Business Development, Commercial and Finance, as a Senior QA Executive / Regional QA Assistant Manager, to • Oversee, manage and execute the QA functions/activities, • Support and implement regional QA projects, • Ensure compliance to QA regulations. Job Responsibilities: • Update/maintain the Quality management system compliance of SciGen. • Coordinate and attend external audits/inspections from regulatory bodies or health authorities such as HSA or partners and support QA audits in other regions. • Create, review and maintenance of QA SOPs, WI, forms, reports, SMF, Quality Agreements, etc in the Document Management System (DMS). • In-charge of the DMS and reviewing all other GxP documents. • Track and liaise with contract manufacturers, distributors and partners on product complaints, temperature excursions, deviations and all other quality events. • Provide QA training to internal stakeholders as needed. • Perform timely release of products and materials. • Review, inspect and approval of artworks. • Assist in product quality issues such as deviations or product recall, where necessary. • Coordinate and perform mock recall. • Manage Internal and external Change Controls. • Assist in Qualification of external vendors/service providers/suppliers. • Perform QA Due Diligence Check for new products. • Management of external vendors/service providers/suppliers. • Management of secondary packaging site in SG and secondary packaging process. • Conduct external vendor/service provider/supplier audits as needed. • Conduct internal audits. • Provide monthly/quarterly QA updates. • Conduct/Coordinate periodic Management Review meeting. • Serve as QA Management Representative back up. • Handle ad-hoc duties and projects as assigned. Requirements: • Bachelor’s degree in Life Science or equivalent with at least 5 years of relevant work experience with good exposure of QA in the Pharmaceutical/medical device industry. • Strong written and oral communication skills. Technical report writing skills is an advantage. • Able to work independently and collaboratively. • Experience working in a cross-functional, matrix environment. • Able to manage multiple priorities and meet scheduled milestones. • Proficient with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, etc).