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).
