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Fortrea
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Regulatory Operations Principal Specialist

Regulatory Operations Principal Specialist

Fortrea

0 years

0 Lacs

Mumbai Maharashtra India

Posted:1 week ago| Platform:

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Skills Required

support management reports compliance risk documentation combination development data analysis evaluation coordination resolve

Work Mode

On-site

Job Type

Full Time

Job Description

Support to Product Quality Management team:
Deliver technical reports fully in compliance with cGMP's
Work with the team to execute risk management processes, procedures and documentation required to support quality risk management program.
Providing quality oversight to new combination product development as well as lifecycle management.
Collaborate and build trusting relationships with all stakeholders and business partners in identifying opportunities for improvement and meeting goals and objectives.
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.

Learn more about our EEO & Accommodations request here.

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Regulatory Operations Principal Specialist