operations
Posted 15 hours agoRegulatory Operations Principal Specialist
at Fortrea
Mumbai, IndiaRemote
Responsibilities
- Deliver technical reports fully in compliance with cGMP's Collaborate and build trusting relationships with all stakeholders and business partners in identifying opportunities 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.
- Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions for technical documentation related activities, coordinate the issues in a timely manner.
- Ensure client and global regulatory compliance.
Requirements
- Job Overview: Responsible to execute risk management processes, procedures and documentation required to support quality risk management program for surgical procedures and new 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 new combination product development as well as lifecycle management.
- Qualifications (Minimum Required): Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with
- experience of 7-9 years. “Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.” OR Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 79 years of
- experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of
- experience will be preferred. “Fortrea may consider relevant and equivalent
- experience in lieu of educational requirements.” Speaking-English and/or other languages as applicable.
- experience in project management and people management is desirable. Industry experience of which 7-9 years of
- experience in the job discipline (e.g.
- Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.