Website Baxter

Job Summary

• Job Title –Research Associate II

• Location – Whitefield, Bangalore

• Shift – General

 Job Responsibilities:

  • Provide technical support and leadership for life cycle management activities for the products of interest
  • As Change Owner, define, organize, plan and execute activities related to product design change and new product registration in compliance with current international/regional/national regulations with minimal support of senior colleagues or independently.
  • Provide technical assessment and strategy for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement and new registrations in collaboration with senior scientists.
  • Lead, and coordinate – including follow-ups as required with global stakeholders – of technical activities in collaboration with key stakeholders, with respect of project commitment, quality procedures and business needs.
  • Provide technical information, &/or prepare reports based on internal or external data available to formulate response to authorities’ questions.
  • Propose options, work closely with stakeholders and develop action plan for problem-solving, product and process improvement.
  • Establish, maintain and update technical & design documentation according to Good Documentation Practices.
  • Participate in and at times lead multi-functional and international project team for effective collaboration and deliverables
  • Demonstrate excellent internal and cross-functional communication and provide regular status update of activities to senior management & stakeholder.
  • Independently create technically accurate reports with in-depth analyses as required using statistics or other relevant tools and mentor/coach help junior members to create information that can go into such reports.

Qualifications

  • Master’s in chemistry or Pharmacy (or related disciplines) with minimum 5 years of relevant experience or B. Pharm with minimum 7+ years of experience.
  • Demonstrated ability in clear and effective communication (written, oral) and presentation skills to broad set of global stakeholders.
  • Excellent stakeholder management (local and global).
  • A proven track record of leading small to moderate size projects – especially Change Controls in Pharmaceutical industry.
  • Demonstrated ability to work in a matrix environment with multiple stakeholders.
  • A proven track record of effectiveness in a fast-paced environment working in global teams.
  • Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables.

    Skills

  • Adequate orientation towards Kidney care therapies and products with time.
  • Hand-on knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service.
  • Hands-on knowledge of Design Control documentation and process.
  • Working knowledge / familiarity of international/regional/national regulations and standards
  • Demonstrated project management experience where business acumen, prioritization and portfolio management skills are required
  • Experience with Statistics and Six Sigma tools.
  • Ability to work independently.
  • Can effectively communicate with internal and external customers.
  • Demonstrates flexibility and the ability to shift gears between projects comfortably.
  • Fluency in English.
  • Solid computer skills: email, documentation and collaboration tools: e.g. WebEx, Teams, Microsoft Office products, etc

To apply for this job please visit in.linkedin.com.