Senior General Manager, Product Delivery Development

Amneal Pharmaceuticals

5 - 8 years

7 - 10 Lacs

ahmedabad

Posted:3 days ago| Platform:

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Skills Required

automation manager quality assurance concept design iso development manager formulation mentor customer service solid works design engineer

Work Mode

Work from Office

Job Type

Full Time

Job Description

Essential Functions:

Technical owner of work streams within the development of parenteral and inhalation drug delivery systems from concept design to commercialization as required by the project plan
Manage teams of internal, external, and contract resources that design, deliver, validate and maintain manufacturing systems for a drug delivery medical device. Develop and maintain all aspects of Design History File working with internal and external vendors
Owner of authoring and maintaining Design Control documents per various regulatory standards like US-FDA 21-CFR Parts 210, 211 & 820, EU-MDR and relevant ISO standards
- Complete the risk management activities to meet project timescales, device performance and quality requirements
- Ensure that all project inputs and outputs are thoroughly documented, providing a robust and detailed design history file for device developments, acting as a role model for other members of staff in terms of the quality of documentation produced
Develop methods for validation, product performance testing, environmental and shelf-life testing. Review new designs, enhancements, and programs with product developers and the formulation team to support a robust drug-device combination product
Mentor design engineers in development process
Manage budgets, project schedules, and report and resolve project issues. Lead cross-functional partnerships with department heads in R&D, operations, quality assurance, contract manufacturers, and other stakeholders to define project scope, estimates, and seek organizational alignment
Deliver excellent customer service to stakeholders and internal customers, work with Quality Engineers and Regulatory Affairs to ensure device related documentation is maintained per relevant standards. Experience in developing URS for submitting to Assembly Automation vendors.

Skills:

Strong skills in GD&T, DFM/A & DHF documentation Advanced
Risk Assessment methodologies like Fault Tree Analysis, FMEA, Hazard Analysis etc. Advanced
Proficient with Solidworks design software Advanced
Strong skills in developing V&V methods and processes for Functional Test Systems Advanced
Strong background in design, development and validation of injection moulded components Advanced
Experienced in the development of intricate but robust mechanisms Advanced
Experienced in risk assessment and risk management Advanced
Highly detail oriented in design, debug, and documentation work. Intermediate
Ability to plan work and accomplish objectives with minimum direction. Strong written and verbal English language communication skills. Intermediate
Strong skills in creating and making technical presentations to small and large audiences Intermediate
Strong communication and organizational skills Intermediate
High attention to detail, personal initiative, and follow-through Intermediate

Specialized Knowledge:

5-8 years of previous Drug Delivery Device (Auto Injector / Pen injector / inhaler) design or quality experience preferred.

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