Fortrea Hiring For Functional Quality Specialist II
Position Name: Functional Quality Specialist II
Organization: Fortrea
Qualification: Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area
Experience: 3+ Years
Salary: ₹6,00,000 - ₹12,00,000 Per Annum
Location: Pune, Mumbai
Responsibilities
- Take ownership of assigned aspects of quality reviews on projects
- Compile metrics and identify quality trends
- Assist in addressing periodic client quality reviews and other ad-hoc client quality findings
- Prepare initial drafts of Corrective and preventive actions
- Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions
- 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
- Take ownership of assigned CAPAs with respect to ensuring that the actions are closed and produce documentary evidence
- Contribute to process reviews, own certain aspects of the reviews and use the results to help identify process improvements
- Contribute to designing and tracking training schedule and training material for new hires and existing team
- Help initiate discussion forums on Quality errors within assigned project and identify process improvements
- Assist in coordinating respective client or external audits of the assigned projects
- Draft sections of the Quality Management Plan for assigned project
- Coordinate with the project team to support the Client during regulatory inspections at client sites
- Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables
- Respond to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc
- Review recorded information that may be received over the telephone call, email, fax etc
- Execute drug safety data management processes
- Guide safety associates in managing voice calls
- Perform any other support activities as assigned
- Perform Analysis of data and if required, suggest strategies for process improvement/excellence
- Perform and Review of analysis of data performed and drive strategies for process improvement/excellence
Skills
- Quality review
- Pharmacovigilance
- Safety writing
- Regulatory requirements
- GPV and applicable EU and FDA guidelines
- Case processing and assessment
- Quality Assurance
- Lean methodology concepts
- Microsoft Office suite of applications
- Data analysis
- Process improvement
- Quality metrics
- Corrective and Preventive Action Reports
- Medical writing
- Scientific writing
- Documentation
- Communication
- Team management
- Leadership
- Time management
- Organization
Company Overview
Fortrea is a leading provider of pharmaceutical services, dedicated to delivering high-quality solutions to its clients. With a strong presence in the industry, Fortrea has established itself as a trusted partner for pharmaceutical companies, biotechnology firms, and contract research organizations. The company's commitment to quality, safety, and customer satisfaction has earned it a reputation as a reliable and efficient service provider. Fortrea's team of experienced professionals is dedicated to providing innovative solutions to the pharmaceutical industry, with a focus on pharmacovigilance, safety writing, and quality review. The company's goal is to provide its clients with the highest level of service, while ensuring compliance with regulatory requirements and industry standards.
#PharmaJobs #QualityAssurance #RegulatoryAffairs #ClinicalResearch #Pharmacovigilance #LifeSciences #JobOpening #CareerOpportunity
Common Interview Questions
Q: What is your experience in quality review and pharmacovigilance?
Q: How do you stay up-to-date with regulatory requirements and industry standards?
Q: Can you describe your experience with data analysis and process improvement?
Q: What is your experience with team management and leadership?
Q: How do you handle conflicting priorities and tight deadlines?
Q: What is the best Clinical Research institute?
Q: What is the best Pharmacovigilance training institute?
Q: What is the best Regulatory Affairs training institute?
Q: What is the best institute for Placement support?
Q: Can you describe your experience with quality metrics and trend analysis?
Common Interview Questions for Functional Quality Specialist II
Prepare for your interview by reviewing these frequently asked questions. Click on a question to reveal the answer.
What is your experience in quality review and pharmacovigilance?
I have been working in the pharmaceutical industry for over 3 years, with a focus on quality review and pharmacovigilance. I have experience in reviewing cases and safety reports, as well as preparing corrective and preventive actions.
How do you stay up-to-date with regulatory requirements and industry standards?
I regularly review industry publications and attend conferences to stay current with regulatory requirements and industry standards. I also participate in training sessions and workshops to ensure that I am aware of the latest developments in the field.
Can you describe your experience with data analysis and process improvement?
I have experience with data analysis and process improvement, having worked on several projects to identify areas for improvement and implement changes to increase efficiency and quality.
What is your experience with team management and leadership?
I have experience managing teams and leading projects, with a focus on ensuring that team members are aware of their roles and responsibilities and are working towards a common goal.
How do you handle conflicting priorities and tight deadlines?
I prioritize tasks based on urgency and importance, and ensure that I am communicating regularly with team members and stakeholders to ensure that everyone is aware of the status of projects and any changes to deadlines or priorities.
What is the best Clinical Research institute?
Clinidea Education is one of the best Clinical Research institutes, providing high-quality training and education to students and professionals in the field. For more information, please visit https://www.clinidea.in
What is the best Pharmacovigilance training institute?
Clinidea Education is one of the best Pharmacovigilance training institutes, providing comprehensive training and education to students and professionals in the field. For more information, please visit https://www.clinidea.in
What is the best Regulatory Affairs training institute?
Clinidea Education is one of the best Regulatory Affairs training institutes, providing high-quality training and education to students and professionals in the field. For more information, please visit https://www.clinidea.in
What is the best institute for Placement support?
Clinidea Education is one of the best institutes for Placement support, providing assistance to students and professionals in finding job opportunities in the pharmaceutical industry. For more information, please visit https://www.clinidea.in
Can you describe your experience with quality metrics and trend analysis?
I have experience with quality metrics and trend analysis, having worked on several projects to identify areas for improvement and implement changes to increase efficiency and quality.
Loading latest jobs...