Research Associate III (PDO)

Vantive

7 - 12 years

9 - 14 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Medical devices Project management Pharma Customer service Management Risk management Stakeholder management Research Associate Technical support Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Responsibilities:

Act as Solution Lead and Technical expert for new product development projects and lifecycle management activities within R&D Kidney Care Drug Products Organization.
Organize, plan and execute product development or sustaining activities in compliance with current QA/ environmental/ regulations and standards.
Provide technical leadership, mentor and guide the execution scientists in order to get tasks accomplished according to plans, milestones and business needs.
Review and approve Design Control documentation as per the quality procedures and industry standards.
Establish, maintain and update technical specification describing product appearance, characteristics and functions, and associated verification and validation documents
Organize, plan and follow the execution of product changes, supplier changes and labelling tasks related to product development or life cycle management projects.
Support Product Risk Owners with the Design related information and associated failure modes and risks arising from any of the design changes for a given product family
Support worldwide product registration and launch following international/regional/national regulations; provide technical support to authorities questions
Provide resource estimation and forecast to the project managers or project leaders.
Ensure good internal and cross-functional communication at a global front and regular status update of projects

Qualifications and Skills

Master s in chemistry or M. Pharm. with at least 10-12 years of relevant experience or Ph.D. in pharmaceutical or relevant sciences discipline with at least 7-10 experience in solution development of parenteral formulations.
Excellent English verbal and written communication skills
Exposure to medical devices and drug products
Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service
Good knowledge of Design Control documentation and process
Demonstrated project/program leadership in drug/pharmaceutical products
Exposure to Product Risk Management for medical devices and drug products
Working knowledge of international/regional/national regulations and standards
Experience in project management and stakeholder management at a global front
Must be able to able to carry out strategy and vision set by upper management and be able to communicate the vision to more junior associates.
Ability to work independently.

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