[Factory 1] R&D Quality Compliance Officer (Pharmacy/ Organic Chemistry Graduated)

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.

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