Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.
Post : Research Associate III (Hybrid)
Job Responsibilities
• Act as Product Risk Management Owner (PRMO) for Kidney care products
• Understand the PRMO risk management process and drive periodic risk reviews in a timely manner to avoid any non compliance
• Support the Product Design Owners, Technical leaders, Change Control owners for any updates to the risk files (Design failure mode effect analysis (DFMEA), Process failure mode effect analysis (PFMEA) and other required documents
• Support the event based risk review products for the products of interest
• Collaborate with the product design owners, technical experts and all the key stakeholders at a global front for implementing the risk management plan for both the Sustaining Organization and New Product Development projects
• Organize, plan and execute activities in compliance with current QA/ environmental/ regulations and standards
• Co-ordinate with all the global plants and actively participate in quality reviews to monitor the complaints, process or design related changes and associated failure modes
• Organize, plan and follow the execution of product changes, supplier changes and labelling tasks related to life cycle management projects
• Ensure good internal and cross-functional communication at a global front and regular status update of projects.
Candidate Profile
• Master’s in chemistry or M. Pharm. with at 9+ years of relevant experience
• 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
• Good knowledge of risk management process of drug products and medical devices
• Demonstrated project/program leadership in drug/pharmaceutical 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. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
Additional Information
Experience : 9+ years
Qualification : MSc, M.Pharm
Location : Bengaluru, Karnataka, India
Industry Type : Pharma/ Healthcare/ Clinical research
Job Category : Regulatory Affairs
End Date : 30th April 2024
See All M.Sc Alerts M.Pharm Alerts Ph.D Alerts Bangalore Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
