Mô tả công việc
1. Quality System Management
Supervise GxP training activities, including setting up GxP and Halal training programs and monitoring training effectiveness.
Act as a GMP trainer for plant employees.
Ensure compliance with GMP requirements in relevant departments such as the warehouse.
Monitor and implement corrective and preventive actions (CAPA) related to quality events.
2. Self-Inspection & Audits
Develop and execute self-inspection plans in accordance with company procedures.
Participate in regulatory inspection handling: Global Quality Audit, GMP inspection by DAV, TGA, GMP for cosmetics by DAV, Halal by LPOM MUI, HS...
Track and follow up on corrective and preventive actions (CAPA).
3. Quality Performance Monitoring
Implement QMI (Quality Management Indicators) and QCMA (Quality Control Maturity Assessment) programs as per the defined frequency.
Monitor, summarize, and report results to managers.
4. Directive Implementation & Compliance
Update, monitor, and apply quality directives and guidelines from the corporation and regulatory authorities.
Ensure compliance between internal procedures and global quality documents.
5. GxP Documentation Management
Supervise the GxP documentation system, including SOPs, specifications, batch records, procedures, and records.
Issue, supersede, and archive documents following SOPs.
6. GMP and halal training
Supervise GxP training activities, including setting up GxP and Halal training programs and monitoring training effectiveness.
7. Others
Take the Local Admin role for CMS system and back up Local Admin for Event, CAPA, ILI (Investigation & Learning from Incidents), and Change Control (CC) systems.
Support the implementation of quality improvement initiatives within the site.
Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
Support other activities when needed.
Compliance with HSE requirements.
Yêu cầu
Graduated university and have knowledge of operations and pharmaceutical production.
Has experience and used to work in quality assurance system or GMP site.
Perform the capacity to understand key business issues which impact on quality operations and the impact of quality on the commercial operations.
Good knowledge of GMP, HSE system.
Well organized, planning and time management
Good two-way communication, good adaptability to multi-culture environment.
Fluent in English-4 skills
Advanced in using Word, Excel, PowerPoint.
Quyền lợi
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Thông tin khác
Thời gian làm việc
Thứ 2 - Thứ 6 (từ 08:00 đến 17:00)
Thứ 2 - Thứ 6 (từ 06:00 đến 14:00)
Thứ 2 - Thứ 6 (từ 14:00 đến 22:00)
Thứ 2 - Thứ 6 (từ 22:00 đến 06:00)
Theo ca, một tuần xoay ca một lần, nghỉ cố định thứ 7 và chủ nhật
Thông tin chung
Nơi làm việc
- - Hồ Chí Minh: Khu Công Nghệ Cao, Phường Thủ Đức (Thành phố Thủ Đức cũ)