Latest Job role of Head Quality Assurance at Abbott, Interested and eligible candidates can can check out all the details given in the same below.
Job Title:  Head – Quality Assurance
Job Location: VILLAGE MAUZA, Baddi, India
Job Description and Responsibilities for Head Quality Assurance at Abbott:
- Ensure 24 X 7 compliance of Oral Dosage Facility. Track and monitor Quality Management System at Oral Dosage Facility.
- Lead and manage strategic and operational performance of the quality department, ensuring successful delivery of business strategy, Key Performance Indicators and objectives, whilst adhering to regulatory compliance and achieving commercial success.
- To ensure the quality systems are maintain in compliance with Abbott standards.
Ensure failures/ events/ complaints are adequately investigated and to ensure action items and corrective or preventive actions are identified, addressed and successfully implemented. - Ensure implementation of quality risk management and to proactively identifying, scientifically evaluating and controlling potential risks to people safety, product, facility, equipment and infrastructure.
- Review, assess and appraise important product quality and product safety issues and field actions and track execution.
- Decision on batch disposition and on product recall based on root cause identification.
Review and approve compliance report following external (customer / regulatory) audit / corporate audit and ensure compliance. - To review the QMS tracker and ensure that all critical and major QMS documents meet the requirement and up to the mark.
Interact with l&D for new products and projects with reference to development, scale-up and trials. - Evaluate and approve major change controls, support investigation and approval and closure of change controls, deviations, OOSs, market complaints.
- To ensure review of batch documentation and timely release of batches for distribution.
Suggest improvement I simplification in product presentation/ packing/ quality. Streamlining processes and removing bottlenecks. - Responsible for working in collaboration with RA, l&D, MS&T and Business Development for identification of new products and its evaluation. Evaluate technology transfer from I&D and other sites.
- Respond to queries / notices from FDA authorities and ensure appropriate investigations wherever required.
- Setting KRA for subordinates, monitoring and mentoring the team for achieving set goals. Executing performance review identifying the training and development needs of staff and arranging for requisite training. To develop talent with appropriate skills and competency.
- To conduct self-inspection/ internal audit as per site Internal Audit Program. To investigate and provide CAPA for self-inspection / internal audit and external audit observation. Making sure that internal audits are performed.
- To ensure GMP related training to people at site.
- To ensure timely review, approval and closure of Annual Products Review.
- To identify action items of product quality issues from quality trends and product reviews.
- To notify contract giver for any kind of undesirable event which may have potential to harm product, process or people and to ensure balance between service level agreement and compliance.
- To escalate compliance risk to Head Quality.
- To ensure effective implementation of actions items derived from QRM.
- To conduct GEMBA rounds from time to time and ensure system compliance at all times.
Qualification we seek in you!
B. Pharma / M. Pharma / M.Sc.
Possible Interview Questions may be asked for Head Quality Assurance at Abbott
- How do you ensure compliance with regulatory requirements and quality standards in your previous role?
Answer: In my previous role, I ensured compliance with regulatory requirements and quality standards by implementing a robust quality management system. This included conducting regular audits, both internally and externally, to assess compliance and identify areas for improvement. I also maintained strong relationships with regulatory authorities and stayed updated with changes in regulations and guidelines. Additionally, I facilitated training programs to educate staff on quality procedures and implemented effective documentation systems to ensure traceability and accountability.
- Can you provide an example of a situation where you faced a quality-related challenge and how you resolved it?
Answer: In my previous role, we faced a significant quality issue with a product batch that did not meet specifications. I immediately initiated an investigation to identify the root cause. I collaborated with cross-functional teams, including production, quality control, and research and development, to conduct a thorough analysis. We implemented corrective and preventive actions to address the issue, such as revising manufacturing procedures, enhancing quality control measures, and providing additional training to the production team. Through our diligent efforts, we successfully resolved the quality issue, preventing its recurrence and ensuring product quality.
- How do you promote a culture of quality and continuous improvement within your team?
Answer: I believe in fostering a culture of quality and continuous improvement within the team by promoting open communication, collaboration, and knowledge sharing. I encourage team members to actively participate in quality improvement initiatives, such as conducting risk assessments, implementing process enhancements, and suggesting innovative ideas. I also organize regular quality-focused meetings and training sessions to keep the team updated with industry best practices and emerging trends. By recognizing and rewarding excellence in quality performance, I motivate team members to strive for continuous improvement.
- How do you ensure effective implementation of quality systems and processes across different departments?
Answer: Ensuring effective implementation of quality systems and processes across different departments requires clear communication, strong leadership, and collaboration. I establish strong relationships with department heads to ensure alignment and understanding of quality objectives. Regular meetings and cross-functional team discussions help to identify potential areas of improvement and address any quality-related challenges. I also provide guidance and support to department heads in implementing quality procedures and monitoring their compliance. By fostering a sense of shared responsibility and accountability, I ensure that quality is ingrained in the culture of the organization.
- How do you stay updated with the latest trends and advancements in quality assurance practices?
Answer: To stay updated with the latest trends and advancements in quality assurance practices, I actively participate in industry conferences, seminars, and workshops. I also subscribe to professional journals and publications, follow relevant regulatory agencies’ updates, and network with professionals in the field. Additionally, I engage in continuous professional development by pursuing relevant certifications and attending training programs. By staying informed about industry best practices and emerging technologies, I ensure that our quality assurance practices are up to date and aligned with industry standards.
