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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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Type
Full-time
Work mode
On-site
Level
Staff
Industry
Pharmaceuticals / Biotech
Salary
Thương lượng
Location
Bình Dương, Thành phố Thuận An, Bình Dương

Overview

  • 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

Benefits

HealthcareTraining

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