Cepheid QA Validation Associate Job For Biology Candidates – Apply Online

Cepheid  

Category: Quality & Regulatory Affairs  

Job Id: R1243572  

Location: Bangalore, Karnataka, India

The Quality Validation Associate position that supports quality systems activities related to software validation, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects or activities using existing procedures and under direct supervision.

This position is part of the Cepheid Quality Team and will be located at Danaher India Development Center (IDC), Bengaluru, Hybrid. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Perform duties as an individual contributor and/or team member with 100% hands-on work
• Participate in creating and updating of test protocols, the submission, execution, and review of test protocols in accordance with SOPs
• Record, report, and verify software defects to accurately depict the software requirements
• Participate in test design reviews and work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects
• Participate in Validation to ensure the software meets user needs requirements of user workflows for a regulated environment
• Provide test data to drafts of validation report, update traceability matrices and quality metrics
• Create change orders in document control system
• Participate in daily management using DBS tools

The essential requirements of the job include

• BE/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field.
• 2+ years of software validation testing experience in a regulated environment.
• Understanding of FDA and ISO regulations, e.g., design controls and risk management
• Excellent interpersonal, writing and communication skills, and troubleshooting skills and passionate about testing, product quality, and customer satisfaction.
• Experience with: Windows environments, Web application testing, and working knowledge of SQL, including the ability to run queries, and interpret results.

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Hybrid Job Posting Language:

At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.  Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

APPLY ONLINE

Here are five possible interview questions for the role of QA Validation Associate, along with their answers:

Question 1: Can you explain your experience with software validation in a regulated environment? How have you ensured compliance with FDA and ISO regulations, particularly in terms of design controls and risk management? Answer: Certainly. In my previous roles, I’ve been actively involved in software validation activities, ensuring that the software meets the required quality standards and regulatory guidelines. I’ve worked with cross-functional teams to create and update test protocols in accordance with SOPs. Additionally, I’ve focused on design controls and risk management, aligning our validation processes with FDA and ISO regulations to ensure the safety and effectiveness of the software.

Question 2: Could you share a specific example of a software defect you identified during testing and how you accurately reported and verified it against the software requirements? Answer: Of course. In a recent project, I discovered a software defect that was affecting the accuracy of a critical calculation module. I immediately documented the defect, including the steps to reproduce it and the expected behavior. After further testing, I confirmed the issue and its impact on the software’s functionality. This detailed reporting allowed the development team to address the defect promptly.

Question 3: How have you collaborated with the Software Engineering team to address design issues and software defects during the validation process? Answer: Collaboration with the Software Engineering team is vital for successful software validation. In my previous roles, I’ve actively participated in test design reviews and worked closely with the development team to address design issues and software defects. By fostering open communication and sharing insights, we’ve been able to resolve issues efficiently and ensure the software aligns with user needs and regulatory requirements.

Question 4: Can you provide an example of how you’ve contributed to the creation of validation reports and traceability matrices to demonstrate compliance and quality metrics? Answer: Certainly. In a recent validation project, I provided essential test data and results that were used to create a comprehensive validation report. I also updated traceability matrices to ensure that each requirement was appropriately tested and documented. This meticulous documentation not only demonstrated compliance but also provided a clear picture of the software’s performance and quality metrics.

Question 5: How do you stay updated on evolving FDA and ISO regulations related to software validation in a regulated environment? Answer: Staying current with regulatory changes is crucial for successful software validation. I regularly attend industry seminars, webinars, and workshops that focus on FDA and ISO regulations. I also engage with regulatory forums and online resources to gain insights into the latest updates. By actively seeking knowledge, I ensure that our software validation processes align with the most up-to-date standards and guidelines.

These answers are provided as samples. It’s important to tailor your responses based on your own experience and understanding of the role and industry standards.

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