At a Glance
- Tasks: Oversee QA functions, manage compliance, and support regional QA projects.
- Company: Leading pharmaceutical company focused on quality and innovation.
- Benefits: Competitive salary, professional development, and a dynamic work environment.
- Other info: Collaborative culture with opportunities for growth and learning.
- Why this job: Join a vital role ensuring product quality and compliance in healthcare.
- Qualifications: Bachelor’s in Life Science and 5 years of QA experience required.
The predicted salary is between 40000 - 50000 € per year.
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, and 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 maintain 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 approve 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 meetings.
- Serve as QA Management Representative backup.
- 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 to 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).
Quality Assurance Executive (12-month Contract) employer: SCIGEN PTE. LTD.
At SciGen, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and professional growth. Our commitment to employee development is reflected in our comprehensive training programmes and the opportunity to engage with diverse functions across the pharmaceutical industry. Located in Singapore, we provide a dynamic environment where you can make a meaningful impact while enjoying competitive benefits and a supportive team atmosphere.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Executive (12-month Contract)
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and medical device industry. Attend relevant events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your QA knowledge. Familiarise yourself with the latest regulations and compliance standards in the industry. We recommend practising common interview questions related to quality assurance to boost your confidence.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your experience with QA functions, audits, and compliance projects. This can be a great conversation starter during interviews and will help you stand out from the crowd.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities waiting for you. Plus, applying directly can sometimes give you an edge over other candidates. So, get your application in and let’s get you that Quality Assurance Executive role!
We think you need these skills to ace Quality Assurance Executive (12-month Contract)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Quality Assurance role. Highlight your QA experience in the pharmaceutical or medical device industry, and don’t forget to mention any relevant projects you've worked on!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the role. Mention specific experiences that relate to the job description, like managing audits or working with cross-functional teams.
Showcase Your Communication Skills:Since strong written and oral communication skills are key for this role, make sure your application is clear and concise. Use professional language but keep it friendly – we want to see your personality shine through!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets to us quickly and efficiently. Plus, you’ll find all the details you need about the role right there!
How to prepare for a job interview at SCIGEN PTE. LTD.
✨Know Your QA Regulations
Make sure you brush up on the latest QA regulations relevant to the pharmaceutical and medical device industry. Being able to discuss these regulations confidently will show that you're not just familiar with the basics, but that you’re also committed to compliance.
✨Showcase Your Cross-Functional Experience
Since the role involves working closely with various functions like Regulatory Affairs and Supply Chain, be ready to share specific examples of how you've successfully collaborated in a cross-functional environment. Highlighting your teamwork skills can set you apart from other candidates.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific quality issues, such as product recalls or deviations. Prepare some real-life examples where you’ve managed similar situations, focusing on your problem-solving skills and attention to detail.
✨Demonstrate Your Training Skills
Since providing QA training is part of the job, think about times when you've trained others or led workshops. Be ready to discuss your approach to training and how you ensure that your colleagues understand complex QA concepts.
