Functional Quality Specialist | Grow with Fortrea Careers | Apply Now
Step into a rewarding role with Fortrea Careers, where professionals passionate about Clinical Research Jobs and PV Jobs can contribute to high-impact global safety operations. The Functional Quality Specialist I position in Pune offers an excellent opportunity for individuals who want to advance within the dynamic world of pharmacovigilance, regulatory processes, and quality oversight. If you’re aiming to grow your expertise and build a thriving future in Clinical Research Jobs and PV Jobs, this role perfectly aligns with long-term career development in Fortrea Careers.
Job Details:
- Position Title: Functional Quality Specialist I
- Job Requisition ID: 255409
- Remote Type: Hybrid
- Locations: Pune
- Time Type: Full time
About the Company:
Fortrea is a global Contract Research Organization (CRO) committed to advancing clinical development, regulatory excellence, and patient safety. As a trusted partner to leading biopharma organizations, Fortrea supports innovation through high-quality operations, making it an ideal destination for candidates exploring Fortrea Careers, Clinical Research Jobs, and PV Jobs.
Job Description:
It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989, and the EC (European Commission) Directives 1992/3 as documented in the Company’s Health and Safety Manual.
Key Responsibilities:
- Perform Quality review of assigned cases.
- Assist in compiling quality metrics based on this review and identifying quality trends.
- Assist in addressing periodic client quality reviews.
- Assist in preparation of Corrective and preventive actions as requested.
- Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers.
- Perform ongoing review of various cases or safety reports for global regulatory submissions, labeling/regulatory documents for Fortrea clients e.g., Annual Reports, PSURs, PADERs, Clinical Study Reports, etc.
- Assist with the overall functional quality operations associated with products including the entire adverse events process.
- Manage and review expeditable adverse events, product quality complaints, and medical information to the required standard.
- Assist in the conduct of process review for assigned process and measure and monitor audit readiness.
- Assist in designing and tracking training schedule and training material.
- Contribute to discussion forums on Quality errors and help identify process improvements.
- Assist in coordinating respective client or external audits of the assigned projects.
- Assist in the development of Quality Management Plan for assigned projects.
- Coordinate with the project team to support the Client during regulatory inspections.
- Perform Analysis of data and suggest strategies for process improvement/excellence.
- Perform and Review analysis of data performed and drive strategies for process improvement.
- Respond to medical information queries/product quality complaints.
- Execute drug safety data management processes.
- Guide safety associates in managing voice calls.
- Perform any other support activities as assigned.
- Contribute to process review and use results to identify the process improvement initiatives.
- Coordinate with the project team to support sponsor during the regulatory inspections or audits.
- Review product quality complaints and medical/general information queries and respond accordingly.
Qualifications Required For Fortrea Careers:
- Bachelors/Masters/PhD degree in relevant fields or equivalent experience.
Experience :
- Two plus years in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with peer review/quality review experience.
Preferred Qualifications :
- Experience in generating quality metrics with trend analysis.
- Knowledge of Medical Device reporting desirable.
