27 Sep
|
Zydus Group
|
Ahmedabad
27 Sep
Zydus Group
Ahmedabad
- Company Name : Zydus Lifesciences Ltd
- Designation : Executive / Senior Executive
- Department: Technology Transfer (OSD - Solid Oral Dosage)
- Location: Ahmedabad Plant
- Qualification: B.Pharm / M.Pharm
- Experience: 3 to 8 Years
- Industry: Pharmaceuticals (Formulation Unit - Tablets, Capsules, Solid Orals)
About the Role
Zydus Lifesciences is seeking dynamic professionals for the Technology Transfer function at its Ahmedabad-based manufacturing facility. The role involves successful scale-up and transfer of pharmaceutical products from development to commercial manufacturing while ensuring compliance with quality, regulatory, and business requirements.
Key Responsibilities
- Execute technology transfer activities for solid oral dosage formulations from R&D; to commercial manufacturing sites.
- Plan and coordinate exhibit, registration, validation, and commercial batches as per approved timelines.
- Evaluate and recommend optimum batch sizes using scientific scale-up principles and equipment capability assessments.
- Prepare, review, and update Master Batch Records (MBR), technology transfer documents, process validation protocols, and reports.
- Coordinate with Production, QA, QC, Regulatory Affairs, Engineering,
and Supply Chain teams for smooth execution of transfer projects.
- Support process validation, revalidation, site-to-site product transfers, and post-approval changes.
- Perform technical troubleshooting during scale-up and commercial manufacturing activities.
- Participate in process optimization, batch size modifications, alternate vendor qualifications, and continuous improvement initiatives.
- Ensure compliance with cGMP, data integrity, regulatory requirements, and internal quality systems.
- Maintain project timelines and provide technical support for product launches and regulatory submissions.
Desired Candidate Profile
- Hands-on experience in Technology Transfer, Scale-Up, Process Validation, or Manufacturing of Oral Solid Dosage products.
- Strong understanding of tablets, capsules, granulation, compression, coating, and packaging processes.
- Knowledge of cGMP, regulatory requirements, validation practices, and pharmaceutical manufacturing operations.
- Valuable analytical, documentation, and cross-functional coordination skills.
- Experience in commercial product launches and site transfer activities will be preferred.
📌 MS&T - Technology Transfer (OSD) (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad