QA/ra Manager
3 days ago
Job Title: Quality Assurance, Regulatory Affairs Manager
Location: Tuas
Working Days: Mon -Fri
Working Hours: 7.45 AM-4.45 PM
**Salary**: Basic up to $5000
Job Duties
- Manage the quality management system and audit program ensuring compliance with the standards and regulatory requirements (cGMP, FDA 21 CFR Part 820, Part 210 & 211, EU MDR, and ISO 13485).
- Provide technical data or information required by Regulatory Authority for import, reimbursement, and product registration.
- Handling company vigilance system with Regulatory Affairs personnel including product recall activity, assisting in assessing the recall class of the product recall, and assuring that the product recall is understood and complied with. Coordinate with each department and provide the required documentation and gain approval for product recalls/withdrawals.
- Independent reviewer for Equipment Qualification/Validation Program, Process, and Method Validation.
- Finalize and set up the specification for approved starting raw and packaging materials, bulk solutions, and finished products that meet the relevant standard and requirements.
- Ensure all company procedures comply with cGMP and ISO requirement and conduct reviews periodically as required.
Job Requirements
- Diploma/Degree in Life Science (Biology, Chemistry, Pharmaceutical) or Engineering.
- Scientifically, provide technical guidance on materials, products, and process evaluation or validation required by regulatory requirements with relevant education and experience.
- In-depth knowledge of the cGMP, US FDA QSR and 21 CFR Part 820, Part 210 & 211, EU MDR, ISO 13485; or equivalent
- Demonstrated success in the preparation of regulatory audits. Working knowledge of managing the quality management systems in medical device or pharmaceutical environment is preferred
WONG MENG KANG
Superform Consulting Pte Ltd
License No.: R1988500/15C7536
**Job Types**: Full-time, Permanent
**Salary**: $4,500.00 - $5,000.00 per month
Schedule:
- Monday to Friday
Supplemental pay types:
- Yearly bonus
**Education**:
- Local Polytechnic Diploma (preferred)
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