Job Overview:
Responsible to execute risk management processes, procedures and documentation required to support quality risk management program for surgical procedures and current combination product development.
Summary of Responsibilities:
Work with the team to execute risk management processes, procedures and documentation required to support quality risk management program. Focus will be on combination products that could be used in surgical procedures so an understanding of surgical procedures will be helpful
Providing quality oversight to current combination product development as well as lifecycle management.
Deliver technical reports fully in compliance with cGMP's
Collaborate and build trusting relationships with all stakeholders and business partners in identifying prospects for improvement and meeting goals and objectives ( This will need calls/meeting in US time )
Collaborate on data driven risk assessments (risk identification, analysis and evaluation) and formulate risk mitigation plans as well as support Corrective and Preventive Action (CAPA)
plan initiatives.
Executing the functions as called out in Standard Operating Procedures.
Coordination of documents in the document management system.
Be accountable to assure quality & compliance with procedures and customer requirements.
Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions for technical documentation related activities, coordinate the issues in a timely manner.
Working with company leadership to define project objectives, processes, policies, procedures and rules.
Well versed with product knowledge.
Participate in cross-functional meetings as needed.
Responsible for cascading relevant information from internal and external meetings to appropriate colleagues.
Assist with the generation, review and implementation of SOPs, Work Instructions, etc.
Qualifications (Minimum Required):
Bachelor’s in pharmacy or related science d
📌 Regulatory Operations Principal Specialist Mumbai (India)
🏢 Fortrea
📍 India