Quality Assurance - Regulatory Officer

Maxbiocare

Địa điểm làm việc: Hà Nội

Hết hạn: 18/05/2024

Chi tiết công việc
Giới thiệu công ty

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Mô tả công việc

Responsibility:
• Responsible for the review and preparation of quality/regulatory documentation to ensure timely submission to TGA and overseas authority.
• Assist in artwork and labelling lifecycle coordination to ensure compliance with current regulatory (Australia and overseas) requirements.
• Assist in the maintenance and implementation of Quality Management System (QMS) including keeping QA/reg documentation up-to-date, maintenance of customer complaint-related documents, analyze trending results for product stability and quality review purposes and other documentation as per regulatory guidelines.
• Liasing with QA department with other tasks relating to product quality documentation
• Provide QA/regulatory support in terms of QA related documentation to NPD (New Product Development) Department.
• Assist in design efforts for various marketing projects , help with reviewing and continuous updating of websites to ensure compliance with applicable regulations.
• Provide relevant administrative support activities relating to overseas product registration.
• Other related task assigned by your manager

Yêu cầu công việc

What do we expect from you:
- Holding a Bachelor or Engineering degree (4-5 years education) with major in Pharmaceutical or Bio-chemical area.
- 1-2 years of experience from graduate.
- English: equivalent to IELTS 6.0.
- Good with Microsoft Word, Excel, data presentation / analysis tools.
Report to:
- QA Manager and Reg Affair Associate.
Means of communication:
- Email
- Instant messaging: Microsoft Teams
- Telephone
Communication:
- Sales staff members in Vietnam and overseas
- Quality and Reg Affair staff overseas.
- Distributors, business partners in Vietnam and overseas.
Workday:
- Full time Monday - Friday.
- Plus 2 Saturday mornings per month.
Who we are:
Max Biocare is a bioscience and healthcare company dedicated to improving the health of families, animals and the environment, through ethical and sustainable research and innovation. We are Australian based, with operations in 10+ South-East Asian countries for 20+ years.
Salary:
- $500 - $800
What we offer for this position:
- Competitive salary and allowance package
- Full salary during probation
- 12 days' work from home and 12 days paid annual leave.
- All employee benefits as per Vietnam's labour laws.
- New year bonus
- Flexible work schedule when needed to support personal needs.
- Annual salary review.
- Opportunities for career advancement and personal development.
- Regular training opportunities
Work location:
Hà Nội

Quyền lợi được hưởng

• Chế độ phúc lợi (BHXH, nghỉ lễ, tết, du lịch...) đúng theo quy định của Luật Lao động và nhiều chế đ
12 ngày
• Môi trường làm việc hiện đại, làm việc trực tiếp với trụ sở Úc. Cơ hội thăng tiến nghề nghiệp ca

Thông tin khác

NGÀY ĐĂNG
18/04/2024
NGÀNH NGHỀ
Dược > Phân Phối Dược Phẩm
LĨNH VỰC
Dược phẩm
CẤP BẬC
Mới Tốt Nghiệp
KỸ NĂNG
Quality Assurance, Regulatory Affair, Đảm Bảo Chất Lượng, Dược Phẩm, Pharmacy
NGÔN NGỮ TRÌNH BÀY HỒ SƠ
Tiếng Anh