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).
