Latest MSc Job at Syngene. Apply Now!
Syngene, a leading research and development organization in India, is actively seeking MSc Life Science candidates for the position of Research Associate I. This is a remarkable opportunity for individuals looking to contribute to cutting-edge research and innovation in the life sciences field. Don’t miss the chance to apply online and join Syngene’s dynamic team!
Job Title: Research Associate 1 (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
Technical/functional Skills:
• 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).
Latest MSc Job at Syngene. The required behavioral skills are:
• 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
Latest MSc Job at Syngene. Examples of interview Q & A to help you with:
1.Can you describe your experience with Computerized System Validation (CSV) and your role in authoring/reviewing yearly reports for User Setup and Configuration Management?
Sample Answer:
In my previous role as a CSV Specialist at XYZ Pharmaceuticals, I had extensive experience in Computerized System Validation. I was responsible for authoring and reviewing yearly reports for User Setup and Configuration Management. My role involved ensuring that all user accounts and configurations were compliant with regulatory requirements. I collaborated closely with the IT team to document any changes and updates to the system, and I conducted regular audits to verify data accuracy. This meticulous approach helped our organization maintain a high level of compliance and integrity in our computerized systems.
2. What is your approach to preparing master validation plans and quality/validation plans for IT systems? Can you provide an example of a successful implementation of these plans in your previous role?
Sample Answer:
My approach to preparing master validation plans and quality/validation plans for IT systems is methodical and thorough. I begin by conducting a comprehensive risk assessment to identify critical aspects of the system. Once risks are identified, I develop detailed plans that outline validation protocols, testing procedures, and acceptance criteria. In my previous role at ABC Biotech, we implemented this approach for a critical laboratory information management system (LIMS) validation. By following the plan meticulously, we not only ensured compliance with industry standards but also improved system efficiency, resulting in reduced errors and increased data integrity.
3. How do you ensure compliance with IT Quality Risk Assessment and Qualification Protocol/Report requirements when validating computer systems?
Sample Answer:
Compliance with IT Quality Risk Assessment and Qualification Protocol/Report requirements is essential in CSV. I prioritize risk assessment early in the validation process to identify potential vulnerabilities and critical components of the system. I then develop qualification protocols that address these risks. During execution, I closely monitor the process, gather data, and document results meticulously. If any discrepancies arise, I work with cross-functional teams to address them promptly, ensuring that the system meets all quality and compliance criteria.
4. Can you share an example of a challenging situation you’ve faced in Computer System Validation and how you resolved it?
Sample Answer:
Certainly. In a previous role, we encountered a situation where a critical manufacturing execution system (MES) needed validation, but it had undergone several changes without proper documentation. This posed a significant challenge as we needed to validate the system while ensuring historical data integrity. To resolve this, I initiated a comprehensive gap analysis and collaborated closely with the IT team to reconstruct the system’s history. We established a robust change control process to prevent similar issues in the future and successfully completed the validation, maintaining both compliance and data integrity.
5. How do you stay updated with the latest regulations and best practices in Computerized System Validation? Can you provide an instance where you applied newly acquired knowledge to improve the validation process?
Sample Answer:
I am committed to staying updated with the latest regulations and best practices in CSV. I regularly attend industry conferences, webinars, and workshops to keep abreast of changes. Additionally, I am an active member of online forums and professional networks focused on validation and compliance. An instance where I applied newly acquired knowledge was when I learned about an emerging best practice in risk-based validation. I introduced this approach in my team, resulting in more efficient and targeted validation efforts, ultimately reducing validation timelines while maintaining compliance.
