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