• Job Title –Research Associate II
• Location – Whitefield, Bangalore
• Shift – General
- 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.
- 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.
- 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
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