Product Quality Officer
3 days ago
**Responsibilities**:
- Lead in the implementation of Quality Management System in accordance with internal company policies and procedures, cGMP and other international regulations.
- Update complaints retrieved from various sources to complaint log in a timely manner and escalate complaints into the CAPA system following review.
- Participate in Product Quality activities by reviewing test protocols and reports to ensure product quality meet the specified requirements.
- Review deviation and risk management for products as required.
- Review product quality documents and provide documents related to product quality upon request.
- Provide management with quality data and trends
- Lead internal audits to ensure the effective implementation of Quality Management System.
- Lead audits in CMOs to ensure compliance to all relevant guidelines, regulations and agreements.
- Support other projects and activities as assigned.
**Education/Qualification**
- Degree in Engineering (Biomedical) or Degree in Science (Biology, Chemistry, Bio-engineering)
- Experience in quality function dealing with Biopharmaceuticals with more than 1 year experience.
**Skills preferred**
- Effective oral and written communication skill
- Strong analytical and problem-solving skill
- Good computer skills, inclined to adapt to technology efficiently
- Good knowledge of regulatory guidelines
- Results-oriented, multi-tasking, quick learner
- Works independently and well under tight deadlines
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