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← CÔNG TY TNHH ROHTO-MENTHOLATUM (VIỆT NAM)

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

CÔNG TY TNHH ROHTO-MENTHOLATUM (VIỆT NAM) · Bình Dương
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Loại hình
Toàn thời gian
Hình thức
Tại văn phòng
Cấp bậc
Nhân viên
Ngành nghề
Dược phẩm
Mức lương
Thương lượng
Địa điểm
Bình Dương, Thành phố Thuận An, Bình Dương

Tổng quan

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Training and Awareness
  • Conduct regular training sessions for staff on compliance management practices.
  • Promote a quality culture within the R&D department.
  • 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.
  • Proficient in MS Office (Word, Excel, PowerPoint)
  • Good command of English (speaking, reading, writing); TOEIC, etc

Quyền lợi

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