21 Aug
|
Zydus Lifesciences
|
Ahmedabad
21 Aug
Zydus Lifesciences
Ahmedabad
Job Title: Sr. Executive / Assistant Manager Packaging Development
Experience: 4-6 Years
Qualification: Graduation in Packaging/ Polymer Technology or an equivalent discipline, with a Postgraduate Qualification in Packaging Technology.
Job Summary:
Responsible for primary packaging and drug delivery device development activities for *Topical, Transdermal, and Inhalation/Nasal products*. The role involves packaging and device selection, vendor qualification, regulatory documentation, exhibit batch support, commercialization, lifecycle management, and cross-functional coordination to support global regulatory filings and product launches.
Key Responsibilities
- Conduct innovator pack evaluation, trade dress assessment, and packaging benchmarking.
- Support COD/COG assessment for recent product opportunities.
- Develop and qualify drug delivery devices such as DPI, pMDI, BAI, and SMI in compliance with regulatory requirements.
- Prepare URS, support for Design History Files (DHF), Design Control documents, and related combination product documentation.
- Identify, qualify,
and finalize primary, secondary, and tertiary packaging components and vendors.
- Execute packaging material qualification, machine trials, and packaging line change-part development with protocol-based reporting.
- Support in cross-functional project meetings and deficiency responses.
- Support exhibit/submission batches through timely availability of packaging materials, specifications, STPs, and batch documentation.
- Monitor shop-floor activities and troubleshoot packaging issues during development, exhibit, and commercial batches.
- Prepare packaging development reports and technical documentation.
- Support ANDA filings and regulatory responses by providing packaging-related technical documents and certifications.
- Design commercial pack configurations, conduct transportation studies, and support product launch activities.
Manage lifecycle changes including artwork revisions, alternate vendo
📌 Sr. Executive (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad