Manager - Packaging

3 weeks ago

Navi Mumbai, Maharashtra, India Thepharmadaily Full time
Job Description

Key Stakeholders

- Internal: Supply Chain, R&D, Quality Assurance, Regulatory Affairs, Manufacturing
- External: Vendors, Consultants

Reporting Structure

- Reports to: Chief Manager Packaging Technology

Relevant Experience

- Bachelor's degree with 1015 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

Key Responsibilities

- 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

Key Competencies

- 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

Qualifications

Essential

- BS in Mechanical Engineering or
- Graduate in Packaging Technology with strong expertise in:
- Medical device development
- R&D product packaging development

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