30 Oct
|
Emcure Pharmaceuticals
|
Sanand
30 Oct
Emcure Pharmaceuticals
Sanand
Department: Technology Transfer Designation: Officer
Experience:
3-6 Years Industry: Pharmaceutical (Sterile Injectables) Job
Location:
Sanand, Ahmedabad
Key Responsibilities
• Support Technology Transfer (TT) activities for new product introductions and commercial products.
• Prepare, review, and maintain technology transfer documents, BMRs, BPRs, SOPs, protocols, and reports.
• Coordinate with R&D;, Production, QA, QC, Engineering, Regulatory Affairs, Warehouse, and Packaging Development teams for seamless product transfer.
• Participate in process validation, batch execution, scale-up, and exhibit batch activities.
• Track project timelines and ensure timely completion of TT milestones.
• Support change control, deviation, CAPA, and risk assessment activities related to technology transfer.
• Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
• Assist in troubleshooting and implementation of process improvements during product transfer and commercialization.
Qualifications &
Skills:
• Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
• Strong understanding of sterile injectable manufacturing processes.
• Knowledge of Technology Transfer, Process Validation, Scale-up, Change Control, and Risk Assessment.
• Familiarity with cGMP, GDP, and regulatory compliance requirements.
• Strong documentation, communication, coordination, and cross-functional stakeholder management skills.
• Proficiency in MS Office and electronic documentation systems. Experience Required:
• 3-6 years of experience in the pharmaceutical industry.
• Mandatory experience in Sterile Injectable Manufacturing.
• Hands-on exposure to Technology Transfer, Recent Product Introduction (NPI), Process Validation, and Commercialization Activities preferred.
📌 Technology Transfer Officer (Sanand)
🏢 Emcure Pharmaceuticals
📍 Sanand