Formulation & Development _Tech Transfer ( Officer / Executive ) OSD

Position Title:

Job Overview:

The Team Member will support the successful transfer of products from development to manufacturing by ensuring process accuracy, documentation integrity, and adherence to quality standards. This role involves close collaboration with cross-functional teams, participation in validation processes, and troubleshooting to optimize manufacturing efficiency.

Key Responsibilities:

1. Process & Documentation:

• Prepare Technology Transfer Dossiers (TTD) and ensure the accuracy and completeness of all transfer documents, including SOPs and batch records.

2. Validation Support:

• Assist in process and equipment validation activities, ensuring alignment with manufacturing and regulatory requirements.

3. Risk Management:

• Identify potential risks during technology transfer and collaborate with relevant teams to implement mitigation strategies.

4. Collaboration:

• Work closely with cross-functional teams, including R&D, Quality Assurance, and Production, to ensure a seamless transfer process.

5. Troubleshooting:

• Resolve issues encountered during the transfer process and manufacturing runs, and implement practical solutions.

6. Training:

• Support and participate in training programs for team members to ensure understanding of processes and compliance requirements.

7. Compliance:

• Ensure adherence to all regulatory and quality standards throughout the transfer process and during manufacturing.

8. Reporting:

• Maintain accurate and comprehensive project documentation to support future references and regulatory inspections.

Key Skills:

Technical Skills:

• Knowledge of GMP, process validation, and regulatory standards.
• Familiarity with product development, manufacturing, and technology transfer processes.

Soft Skills:

• Strong communication and collaboration abilities for effective teamwork.
• Analytical thinking and problem-solving skills to address challenges.
• Attention to detail to ensure accuracy and compliance.

Qualifications & Experience:

• Education:

  B. Pharm or Master of Science (M. Sc).

• Experience:

• 4-7 years of experience in product development, manufacturing, and technology transfer.

• Skills:

• Hands-on expertise in GMP, validation processes, and adherence to regulatory guidelines.