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. Fortea has a BSc chemistry Pharmacy job as an auditor role. Apply online after finding here the details for the BSc chemistry Pharmacy job.
Job ID – 2343810
Job role – QA Compliance Lead Auditor
Location – Bangalore, Pune, Mumbai India
Essential Job Duties:
- Conduct work as identified on the audit activity table (listing on the table is not all-inclusive but a representative sample)
- Takes lead in the generation of global QA policies on the interpretation/ application of regulations
- Provide subject matter expertise and leads/influences the ED/CS/CDS/CLS organization by providing guidance and client/authority-facing support on specific niche regulatory topics
- Hosts (i.e. for cause inspection, non-standard authority inspections, country-specific or scope of inspection) external audits/inspections e.g. regulatory inspections, strategic clients.
- Facilities and reviews responses to the audit.
- Leads the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forums (e.g. Monthly Reports, Site Quality Review, Liaison meetings).
- Manage (for own area of expertise) / participate (for multi-regulatory topics) in broad-scope global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
- Acts as a backup for QA Manager; provides a monthly report of activities to QA Manager; performs other related duties as assigned
- 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:
- 8 years in the regulatory environment (experience in GXP roles)
- Regulatory expertise – detailed knowledge of specific regulation/ multiple regulations
- Experienced Lead Auditor
- Strategic communication with clients
- Experience leading process improvement initiatives
Education/Qualifications/Certifications and Licenses:
A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline
Postgraduate degree (MSC or equivalent) in science or management-related discipline, preferable. Experience may be substituted for education.
Hello there, You can go through the expected interview questions and answers provided here. It will help you when you are preparing for the interview for the BSc chemistry Pharmacy job as lead auditor. All the very best for your interview.
Can you describe your experience in the regulatory environment and your role in ensuring compliance with regulations?
Answer: I have over 8 years of experience working in the regulatory environment, specifically in GXP roles. Throughout my career, I have gained a detailed knowledge of multiple regulations and have actively ensured compliance with them. As a lead auditor, I have conducted audits and inspections to assess compliance and identify areas for improvement. I have also taken the lead in generating global QA policies to interpret and apply regulations effectively.
How have you provided subject matter expertise and guidance on niche regulatory topics to the ED/CS/CDS/CLS organization?
Answer: I have been actively involved in providing subject matter expertise and guidance to the ED/CS/CDS/CLS organization on specific niche regulatory topics. This involves staying updated with the latest developments in regulations and sharing my knowledge with colleagues. I have conducted training sessions, prepared educational materials, and provided one-on-one support to ensure a thorough understanding of regulatory requirements. Additionally, I have acted as a point of contact for client and authority-facing interactions related to regulatory topics.
Can you provide an example of a time when you hosted external audits/inspections, such as regulatory inspections or inspections for strategic clients?
Answer: In my previous role, I hosted a regulatory inspection by a government authority. I coordinated all the necessary preparations, including organizing the inspection team, ensuring the availability of required documentation, and coordinating with various departments to address any potential compliance gaps. During the inspection, I served as the primary point of contact for the inspectors, addressing their queries and providing them with the necessary information. The inspection went smoothly, and we received positive feedback from the regulatory authority regarding our compliance efforts.
How have you contributed to quality metrics reporting and implemented corrective actions/process improvements in previous roles?
Answer: As part of my responsibilities, I have led the reporting of quality metrics and the implementation of necessary corrective actions and process improvements. I have actively participated in forums such as Monthly Reports, Site Quality Review, and Liaison meetings to present quality metrics, identify areas of concern, and propose corrective actions. By analyzing the metrics and collaborating with cross-functional teams, I have successfully implemented process improvements that enhance compliance and efficiency within the QA organization.
Can you describe your experience in leading process improvement initiatives and how they have contributed to regulatory compliance and overall efficiency?
Answer: Throughout my career, I have led various process improvement initiatives aimed at enhancing regulatory compliance and overall efficiency. I have employed methodologies such as Lean Six Sigma to identify bottlenecks, streamline processes, and eliminate waste. By engaging with stakeholders, analyzing data, and implementing targeted solutions, I have successfully achieved measurable improvements in compliance metrics and operational efficiency. These initiatives have resulted in enhanced productivity, reduced risks, and improved customer satisfaction within the organizations I have worked with.
