[Factory 1] Quality Compliance Officer

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.