Syngene MSc Life Sciences Job – Apply Online For Research Associate Post
Syngene MSc Life Sciences Job – Apply Online For Research Associate Post. MSc Life Sciences job opening at Syngene. Interested and eligible applicants can check out all of the details on the same below
Research Associate 1 1 1
Job ID: 54816
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).
Behavioural 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
Here are five possible interview questions that can be asked in the technical round for the Research Associate position, along with their answers:
1. Question: Can you elaborate on your experience with Computerized System Validation (CSV) processes and how you have contributed to the development of validation plans and reports? Answer: Certainly. In my previous role, I actively participated in preparing master validation plans and reports, as well as quality/validation plans and reports. I ensured compliance with relevant regulatory requirements and worked on documents such as functional and technical design specifications, User Requirement Specification (URS), Installation Qualification (IQ), and Operational Qualification (OQ) plans. This involved meticulous attention to detail and collaboration with subject matter experts.
2. Question: How familiar are you with regulatory requirements such as GXP, 21 CFR Part 11, and Good Automated Manufacturing Practice (GAMP) in the context of Computer System Validation? Answer: I have a strong understanding of regulatory guidelines such as GXP, 21 CFR Part 11, and GAMP. These regulations outline the standards and practices that govern Computer System Validation in the life sciences industry. I’ve applied these guidelines to ensure that our validation processes align with the required quality and compliance standards.
3. Question: Describe a situation where you had to perform Corrective Action Preventive Action (CAPA) and Root Cause Analysis (RCA) related to Computer System Validation. How did you approach the process? Answer: In a recent project, we encountered an issue during the validation of a critical software component. I initiated a CAPA process by first identifying the root cause of the problem through thorough RCA. Once the root cause was determined, I developed and implemented corrective actions to address the issue. This process helped us not only resolve the immediate challenge but also improve our validation procedures moving forward.
4. Question: Can you share an example of a challenging situation you’ve faced while executing a validation test for a computerized system? How did you manage the situation? Answer: During a validation test, we encountered unexpected deviations in the performance of a software module. To address this, I first verified the test environment and configuration. After identifying a potential configuration discrepancy, I worked closely with the technical team to resolve the issue. This experience reinforced the importance of thorough test planning and collaboration with IT experts.
5. Question: The role requires working under strong time pressure. Can you provide an instance where you successfully managed multiple validation tasks within a tight timeline? Answer: In a previous project, we had to validate a complex software system within a tight deadline due to project constraints. I prioritized tasks, streamlined documentation processes, and collaborated closely with cross-functional teams to expedite the validation process without compromising quality. This experience showcased my ability to handle time-sensitive situations effectively.
Remember, these answers are examples and should be tailored to the candidate’s actual experiences and skills.
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