Research Associate 5+yrs Job in Rangam Infotech Pvt. Ltd.

Job Summary Job Description

Job Responsibilities:
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 as required using statistics or other relevant tools and mentor/coach help junior members to create information that can go into such reports
Qualifications
Masters in chemistry or Pharmacy (or related disciplines) with minimum 3 years of relevant experience or B. Pharm with minimum 5+ years of experience
2+ years experience in managing change controls for pharma in-particular for drugs is required. This experience should include working with at least two of the three regulations EP, USP and JP.
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.