Quality Assurance - Regulatory Officer

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

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:

- $600 - $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