Responsibilities:

• Support other activities relevant to quality issues
• Ensure the project management in alignment with the established organizational objectives
• Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
• Prepare documentation for regulatory purposes and coordinate with RA for drug dossier/variation filing and addressing deficiencies; provide relevant documents to RA in a timely manner for drug dossier/variation filing.
• Manage, review and challenge the project budget plan and track the expenses as needed

Qualifications:

• Bachelors or Master's degree in Pharmacy, Industrial Pharmacy.
• 10+ years of experience in manufacturing pharmaceuticals.
• 5+ years of experience as R&D Manager position.
• Knowledge of PIC/s GMP and quality requirements related to pharmaceuticals including ICH, ASEAN Guideline.
• Must be proficient in computer skills & software applications such as Microsoft Office tools.
• Must be able to work under minimal supervision and able to work independently and in a team environment.
• Must possess strong documentation and technical writing skills; and able to apply relevant scientific principles and practices.
• Good communication Skills, Leadership Skills and Strategic Thinking Skills.
• Good command of English Language.