Quality Assurance Executive

Job Summary:

• 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).