Fortrea Life Sciences QA Specialist Job Opening – Apply Online
Fortrea Life Sciences QA Specialist Job Opening – Apply Online. BSc life sciences jobs at Fortrea. Interested and eligible applicants can check out all of the details on the same below
Possible Interview Questions for the Technical Round are posted below:
QA Specialist
Location:
- Bangalore India
- Pune India
- Mumbai India
Job ID: 2344167
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Description:
Essential Job Duties:
- Development and delivery of training (to operational groups)
- Provide advice and guidance on aspects of quality and compliance
- Provide consultation to the operational team on quality issues
- Support in tracking and progression of Quality records
- Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency
- Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
- Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Other duties as assigned by management.
Experience:
Minimum Required:
- 4 years in the regulatory environment (experience in GXP roles)
- Able to influence QA strategy
- Ability to communicate with groups
- Knowledge of multiple operational areas
- Knowledge of industry quality systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios
Education/Qualifications/Certifications and Licenses:
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
Possible Interview Questions for the Technical Round:
- Can you explain your experience in the regulatory environment and GXP roles? How have you applied your knowledge of industry quality systems/standards to ensure compliance in your previous roles?
- Answer: In my previous roles, I have gained extensive experience in the regulatory environment, particularly in GXP roles. I have been responsible for ensuring compliance with industry quality systems and standards, such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), or Good Manufacturing Practice (GMP). I have worked closely with cross-functional teams to develop and implement quality processes, conduct audits, and address any compliance issues identified.
- How do you approach the development and delivery of training to operational groups? Can you provide an example of a training program you developed and its impact on improving quality and compliance within the organization?
- Answer: When developing and delivering training, I believe in a comprehensive and interactive approach. I design training programs that are tailored to the specific needs of operational groups, incorporating relevant regulatory requirements and best practices. An example of a training program I developed focused on data integrity and documentation practices. By emphasizing the importance of accurate and complete record-keeping, we observed a significant improvement in compliance and a reduction in errors related to data integrity.
- How do you ensure regulatory compliance and provide guidance on quality issues within an organization? Can you describe a situation where you had to address a quality issue and provide recommendations for improvement?
- Answer: To ensure regulatory compliance, I closely monitor changes in regulations, guidelines, and industry standards. I work collaboratively with cross-functional teams to develop and implement processes that align with these requirements. In a previous role, we identified a quality issue related to document control. I conducted a root cause analysis, collaborated with stakeholders to develop corrective and preventive actions, and implemented a robust document control system. This resulted in improved compliance, streamlined processes, and enhanced document traceability.
- How do you manage cross-site QA and operational relationships? Can you provide an example of a situation where you collaborated with different sites to improve compliance or efficiency?
- Answer: Managing cross-site QA and operational relationships requires effective communication and collaboration. In a previous role, I collaborated with different sites to harmonize quality systems and standardize processes. By conducting regular meetings, sharing best practices, and fostering open communication, we were able to improve compliance across multiple sites. This collaboration resulted in enhanced efficiency, reduced duplication of efforts, and a consistent approach to quality management.
- How do you stay updated with regulatory changes and apply appropriate regulatory knowledge to ensure compliance? Can you provide examples of how you have adapted to changes in regulations and implemented them effectively?
- Answer: Staying updated with regulatory changes is essential to ensure ongoing compliance. I actively participate in industry conferences, training programs, and regulatory forums to stay informed about the latest developments. In my previous roles, I have successfully adapted to changes in regulations by conducting gap assessments, updating standard operating procedures (SOPs), and providing training to staff on the revised requirements. By fostering a culture of continuous learning and keeping abreast of regulatory updates, I have effectively implemented changes to maintain compliance.
Remember to tailor the questions to the specific requirements of the interview and provide answers based on your own experiences and expertise.
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