Research Associate II

Vantive

0 - 3 years

3 - 7 Lacs

bengaluru

Posted:20 hours ago| Platform:

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Skills Required

research associate ii pharmacy project management process improvement product design customer service raw material portfolio management recruitment six sigma

Work Mode

Work from Office

Job Type

Full Time

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 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 with some supervisions from direct manager and senior members of the organization.
Draft 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
Lead, and conduct activities related to exploration of innovation concepts and technology platforms, demonstrate critical mindset and out-of-the-box thinking.

Qualifications

Master s in Chemistry or Pharmacy (or related disciplines) with minimum 4 years of relevant experience, or PhD in chemistry or Pharmacy (or related disciplines) with experience in Pharmaceutical product development and life cycle management, preferably sterile injectable/parenteral formulations.
Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders
Excellent stakeholder management (local and global)
A proven track record of leading small 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/technology 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.

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