Syngene Hiring MSc Life Science!
Syngene, a leading research and development company in the life sciences industry, is currently seeking MSc Life Science candidates for the position of Research Associate I. This is a fantastic opportunity for individuals with a strong background in life sciences to contribute to cutting-edge research and innovation. Interested candidates can apply online to join Syngene’s dynamic team.
Job Title: Research Associate I (54906)
Company: Syngene
Job Purpose: The position holder is responsible for performing various tasks related to Computerized System Validation (CSV) which includes performing compliance related tasks provided as services from the department from developing plans, execute and deliver the services with acceptable service evaluations.
Key Responsibilities:
• Efficiently author/review yearly reports with respect to User Setup and Configuration Management
• Experience in preparing master validation Plan/Report, Quality/Validation Plan/Report, IT Quality Risk Assessment and Qualification Protocol/Report
• Prepare review and approve the following validation documentation, such as functional and technical design specifications like User Requirement Specification level, Installation Qualification Plan/Report, Operational Qualification Plan/Report etc.
• Should be able to provide guidance to the IT System Subject Matter Expert on questions related to Computer System Validation Experience in test execution and reporting is required
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
• Attend training on environment, health, and safety (EHS) measures imparted company
Educational Qualification: Master’s degree in Life Sciences
Syngene Hiring MSc Life Science candidates. The Technical/functional skills required are :
• Should have experience in performing Corrective Action Preventive Action and Root Cause Analysis
• Should have experience in Computer System Validation and compliance process understanding
• Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, Good Automated Manufacturing Practice (GAMP)
Experience:
• 1-3 years of total experience in Computerized System Validation (CSV).
Behavioral Skills:
• Should be independent
• Excellent communication skills – written and oral in English
• Should have good interpersonal skills
• Large degree of flexibility and ability to work under strong time pressure
Syngene Hiring MSc Life Science candidates. The possible interview Q & A to help you with:
1.Question: Can you walk me through the process of preparing a Master Validation Plan/Report for a computerized system?
Sample Answer:
Sure, when preparing a Master Validation Plan/Report for a computerized system, I start by thoroughly understanding the system’s purpose and intended use. Then, I outline the scope of the validation effort, including the specific functionalities to be tested. I identify relevant regulatory requirements, such as 21 CFR Part 11 or GAMP, and incorporate them into the plan. Next, I establish a validation approach, including the sequence of qualification activities and their dependencies. Throughout the process, I collaborate closely with cross-functional teams and subject matter experts to ensure comprehensive coverage. Finally, I document all these details in the Master Validation Plan/Report, which serves as a roadmap for the entire validation process.
2.Question: How do you prioritize tasks when working on multiple Computerized System Validation projects simultaneously?
Sample Answer:
Prioritizing tasks in a multi-project environment is crucial. I typically start by assessing project deadlines and their criticality to the organization. Urgent projects or those aligned with critical business processes take precedence. I also consider the complexity of each project and the resources available. Additionally, I maintain clear communication with project stakeholders to manage expectations and ensure everyone is aligned on project priorities. This approach helps me allocate time and resources effectively, ensuring that all projects progress smoothly.
3.Question: Could you provide an example of a challenging situation you encountered during a CSV project and how you resolved it?
Sample Answer:
Certainly, in one project, we encountered unexpected discrepancies between the documented system requirements and the system’s actual functionality during testing. This situation posed a significant challenge as it could have delayed the project. To address it, I immediately initiated a root cause analysis to understand why these discrepancies occurred. After identifying the issue as a miscommunication between the development team and end-users, I facilitated meetings to clarify the requirements and bridge the gap. We then updated the validation documentation accordingly, ensuring that the system met user expectations. This proactive approach allowed us to resolve the issue promptly and keep the project on track.
4.Question: How do you stay updated with the latest regulatory requirements, such as 21 CFR Part 11 and GAMP, and ensure compliance in your work?
Sample Answer:
Staying updated with regulatory requirements is essential in the field of Computerized System Validation. I regularly subscribe to industry newsletters, attend relevant seminars, and participate in online forums to keep abreast of the latest regulatory changes. I also make it a point to review guidance documents from organizations like the FDA and OECD. Additionally, I ensure that our validation processes and documentation templates are aligned with the current regulatory standards. This proactive approach helps us maintain compliance and adapt swiftly to any regulatory updates.
5.Question: How do you approach risk assessment in IT Quality and Computerized System Validation?
Sample Answer:
Risk assessment is a fundamental aspect of my work. I start by identifying potential risks associated with the computerized system, including those related to data integrity, system availability, and regulatory compliance. I then assess the impact and likelihood of each risk and prioritize them based on their significance. Collaborating with subject matter experts and stakeholders, I develop risk mitigation strategies, such as validation testing, monitoring, or process improvements. This structured approach ensures that we proactively address and manage risks throughout the validation lifecycle, ultimately enhancing the quality and compliance of our computerized systems.
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