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 II
Job Description
• As Tech Lead or 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 asrequired using statistics or other relevant tools and mentor/coach help junior members to create information that can go into such reports
Candidate Profile :
• 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 Renal PD 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 were 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.
Additional Information
Qualification : M.Pharm or B.Pharm
Location : Whitefield, Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Renal, Solutions
End Date : 20th July, 2021
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