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Manager - Packaging
ConfidentialNavi Mumbai, Mumbai10 days ago
Job descriptionReports to : Chief Manager – Packaging Technology Bachelor's degree with 10–15 years of experience in the pharmaceutical industry (preferably sterile products) or medical device industry Proven experience in : Primary container design and specification development Supporting primary packaging-related regulatory filings Strong project management skills within Packaging and / or Engineering Experience writing technical documentation for regulatory files (e.g., FDA 510(k) and CE Mark ) Deep understanding of global packaging regulations and medical device regulatory requirements Design packaging systems and medical devices for anesthetic drug products, including primary, secondary, and tertiary packaging Support the development of adaptors , integrated closures , kits , and vaporizers Develop 3D CAD models using SolidWorks , including engineering drawings for product components Collaborate with Manufacturing , Supply Chain , and Logistics to identify improvement opportunities Utilize 3D printing / additive manufacturing for prototyping and low-volume production Conduct stability studies , machine feasibility studies , packaging trials , and support regulatory filings Prepare usability and human factor test protocols , conduct testing, analyze results, and compile reports Maintain Design History Files (DHF) and prepare technical documentation for regulatory submissions Develop and improve Design Control and Quality Management System (QMS) procedures Conduct root cause analyses (RCA) and implement corrective / preventive actions (CAPA) Develop and maintain project plans and manage budgets for packaging projects Initiate new packaging projects to drive process improvements and business impact Support sustainability and green packaging initiatives in line with organizational goals Strong knowledge of packaging materials , processes, and technologies, including medical devices In-depth understanding of industry standards and regulatory guidelines Ability to identify and solve packaging design and process issues Skilled in managing multiple projects , timelines, and stakeholder communications Excellent interpersonal and cross-functional collaboration skills BS in Mechanical Engineering or Graduate in Packaging Technology with strong expertise in : Medical device development R&D product packaging development
Key Stakeholders
- Internal : Supply Chain, R&D, Quality Assurance, Regulatory Affairs, Manufacturing
- External : Vendors, Consultants
Reporting Structure
Relevant Experience
Key Responsibilities
Key Competencies
Qualifications
Essential
Skills Required
Fda, Pharmaceutical, 3D CAD, Qms, Capa
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Manager • Navi Mumbai, Mumbai
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