Manager - Material Process Delivery
P&G · JAKARTA GENERAL OFFICE
Full-timeonsitemidOperationsEngineering
รายละเอียดงาน / Description
Based in Indonesia, this role oversees pharmaceutical formulation development and technology transfers across regional contract manufacturing facilities. The manager will lead the scale-up and commercial validation of products while managing supplier qualification, regulatory technical documentation, and stability studies. Frequent regional travel is required to coordinate with cross-functional teams and external manufacturing sites to guarantee seamless execution.
หน้าที่ความรับผิดชอบ / Responsibilities
- Lead technology transfers and commercial scale process validation across contract manufacturing sites in the region.
- Review and approve technical documentation including technology transfer protocols, master formula records, and regulatory dossiers.
- Manage supplier qualification processes for formulation raw materials in coordination with safety and quality partners.
- Maintain quality systems and change control processes using digital document platforms like Veeva.
- Oversee and interpret stability study data in accordance with ICH and WHO guidelines.
- Collaborate with multi-functional teams to resolve technical troubleshooting and support operational improvements.
คุณสมบัติ / Qualifications
- Technical background in pharmaceutical formulation development, process engineering, or a related discipline.
- Experience in technology transfer, manufacturing scale-up, and process validation.
- Familiarity with ICH and WHO stability guidelines and dossier submission standards.
- Hands-on experience with quality systems, deviation handling, CAPA, and Veeva software.
- Ability and willingness to travel regionally between 66% and 75% of the time.
- Strong coordination and problem-solving skills across diverse organizational functions.
ทักษะที่ต้องการ / Required skills
- Technology Transfer
- Formulation Development
- Process Validation
- Contract Manufacturing
- Quality Assurance
- Regulatory Compliance
- Stability Testing
- CAPA
- Veeva
- Technical Troubleshooting
ทักษะเพิ่มเติม / Nice to have
- Dossier Review
- ICH Guidelines
- WHO Guidelines
สวัสดิการ / Benefits
- Comprehensive day-to-day mentoring and leadership guidance.
- Structured formal training and professional development programs.
- Supportive environment encouraging agility and personal well-being.