Syngene Research Associate Life Sciences Job For MSc, Apply Online
Syngene Research Associate Life Sciences Job For MSc, Apply Online. MSc life sciences job opening at Syngene. Syngene vacancies for msc life sciences candidates. Interested and eligible applicants can check out all of the details on the same below
Job role: Research Associate 1
Job ID: 54609
Job Location: India
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
Possible interview questions with answers for the role of Research Associate 1 at Syngene:
1. Can you explain your experience in Computerized System Validation (CSV) and compliance process understanding? Answer: Certainly. I have 1-3 years of experience in Computerized System Validation, which includes preparing and reviewing validation documentation such as User Requirement Specifications, Installation Qualification Plan/Report, and Operational Qualification Plan/Report. I also have a good understanding of the compliance process and have worked with regulatory requirements like OECD, GXP, 21 CFR Part 11, and Good Automated Manufacturing Practice (GAMP).
2. How do you handle Corrective Action Preventive Action (CAPA) and Root Cause Analysis (RCA)? Answer: When dealing with CAPA, I first identify the root cause of the issue or non-compliance. Once the root cause is determined, I develop and implement corrective actions to address the issue and prevent its recurrence in the future. I then monitor the effectiveness of these actions to ensure the problem is resolved successfully.
3. How do you ensure compliance with environment, health, and safety (EHS) measures in the workplace? Answer: I prioritize EHS requirements at all times in the workplace. I am diligent in following safety protocols and guidelines to ensure both personal and collective safety in the lab/plant. Additionally, I actively participate in training sessions provided by the company on EHS measures to stay updated with best practices.
4. Can you describe your experience in test execution and reporting? Answer: Certainly. I have hands-on experience in test execution and reporting during the validation process. I perform thorough testing to ensure that the computerized systems meet the necessary requirements and specifications. I document the testing procedures, results, and any deviations encountered during the process.
5. How do you handle time pressure and tight deadlines while maintaining the quality of your work? Answer: I am well-acquainted with working under strong time pressure. To manage tight deadlines effectively, I prioritize tasks, plan my work, and focus on the most critical aspects first. I also ensure open communication with team members to coordinate efforts efficiently. Despite the pressure, I always maintain a keen eye for quality and accuracy in my work.
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