MÔ TẢ CÔNG VIỆC:
1. Compliance Implementation
- Implement assigned compliance activities to ensure adherence to applicable standards.
- Follow established procedures to support compliance with Good Practices (e.g., GLP, GMP).
- Ensure data integrity (ALCOA+) principles are applied in daily R&D activities.
- Keep updated with relevant regulatory requirements and internal procedures.
2. Change Control & Risk Assessment
- Support to ensure proper documentation and timely submission for change control process.
- Participate in risk assessments related to product development and process changes as assigned.
- Assist in the investigation and documentation of deviations and non-conformances.
3. Documentation & Process Support
- Prepare, review, and maintain R&D documentation to ensure compliance with good practices provisions.
- Support process harmonization activities by following standardized procedures and templates.
4. Cross-functional Coordination
- Coordinate with internal teams including Formulation Development, QA, QC, RA, and other departments for compliance-related activities.
- Support communication and alignment of R&D documentation and requirements across functions.
5. Technical & Operational Support
- Provide support during product registration, validation, and troubleshooting activities when required.
- Participate in analytical method development or related laboratory activities as assigned.
6. Audit & Inspection Support
- Support internal and external audits by preparing required documents and records.
- Assist in tracking and following up audit findings and CAPA actions.
7. Equipment & GLP Compliance
- Ensure proper use and maintenance of R&D equipment in accordance with GLP provisions
- Maintain accurate and complete records related to equipment usage.
8. Training and Awareness
- Conduct regular training sessions for staff on compliance management practices.
- Promote a quality culture within the R&D department.
YÊU CẦU CÔNG VIỆC:
Official Education: Bachelor's degree or master's degree - Major should be related to pharmacy or organic chemistry
Work/ Skills/ Experiences
- 1-2 years in the quality field is preferred
- Have good attention to detail and ability to thoroughly cross check self and others.
- Have a structured and organised approach to document and record management.
- Basic knowledge of regulatory requirements and industry standards.
- Good attention to detail and organizational skills.
- Effective communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Good organizational and time management skills with the ability to prioritize and manage multiple projects and deadlines.
- Flexibility to adapt to frequent project changes.
Supplementary Certificate
- Proficient in MS Office (Word, Excel, PowerPoint)
- Good command of English (speaking, reading, writing); TOEIC, etc
THÔNG :
- Thử việc: 2 months of probation with full salary
- Thời gian làm việc: 44 hours/week
- Cơ hội huấn luyện:
A2E skill training
Pre-mortems
Prioritization
Problem solving
Owner's mindset
Idea generation
Coaching
Influencing
Courageous conversations
Effective communication
Presenting with impact
Closed-loop conversations
Creating business value
Effective meetings
Effective emailing
Organizational health
- Đồng nghiệp: Friendly, supportive
- Ngày nghỉ:
- 15 working days: from full 1 year to less than 3 years;
- 16 working days: from full 3 years to less than 7 years;
- 22 working days: from full 7 years or more to less than 37 years.
- Phúc lợi:
Japanese Health Insurance for Staffs over 2 years contribution
Company trip, Team building activities
Holiday events
- Phụ cấp khác :
Company bus from HCMC to Factory
Parking fee
Meal allowance