Syngene Biotech Job Vacancies

Syngene Biotech Job Vacancies – MSc & BTech Candidates Apply Online

Syngene Biotech Job Vacancies – MSc & BTech Candidates Apply Online. MSc, BTech Biotechnology Job in Syngene, Bangalore. Syngene is hiring Biotechnology candidates for Senior Executive/Junior Manager -Deviation Management and Manufacturing Investigations job.

Don’t forget to check out possible interview questions for the role of Senior Executive/Junior Manager -Deviation Management and Manufacturing Investigations at Syngene below

Job role: Senior Executive/Junior Manager -Deviation Management and Manufacturing Investigations (54214)

Job Location: Bengaluru, India

Reporting to: Function head

Level – 9/8

About Syngene

Syngene International Ltd (https://www.syngeneintl.com/) is an integrated research, development, and manufacturing organization providing scientific services – from early discovery to commercial supply. We offer services in a wide range of industrial sectors, including pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical companies. Our culture of scientific innovation is driven by the expertise of our highly qualified team of 5,000 employees and is supported by state-of-the-art infrastructure and market-leading technology.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit.

Core Purpose of the Role

Objective of this role is to perform Deviation and Out of Specifications Investigations as per global quality standards and regulatory expectations for Biologics Operations.

Role Accountabilities:

  • Timely reporting of deviations and perform appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
  • Perform appropriate manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence.
  • Participate in the audits as SME for OOS investigations and manufacturing investigations.
  • Timely tracking of Operational and Compliance Metrics for Manufacturing Operations and management reporting.
  • Ensure Risk Management for Biologics Operations covering following elements and ensure proposal and implementation of appropriate risk mitigation actions (CAPA)
  • Perform and support timely preparation, review and approval of GMP documentations.
  • Conduct and/or support training on SOPs, protocols and On-the-Job activities.
  • Timely proposal and implementation of appropriate CAPA for audit findings.
  • Participate in regular facility walkthroughs and internal audit for Biologics Operations to ensure adherence to the implemented systems and compliance with regulatory requirements including Data Integrity assessment.
  • Support for implementation of Operational Excellence Initiatives for the Operating Unit (OU).

Education

M.Sc/B.Tech in Biotechnology

Relevant experience

3-8 years of relevant work experience in Biotech company

Professional Skills and Capabilities

  • Excellent technical writing and presentation skills.
  • Hands-on experience on GMP Investigations with use of Root Cause Analysis (RCA) tools will be preferred.
  • Excellent communication and conflict management skills.
  • Knowledge and experience on the concept of Risk Management (System Level, Component Level and/or other suitable tools)
  • Working experience with cross functional teams.

APPLY ONLINE HERE

💡 Here are a few possible interview questions for the Syngene, Senior Executive/Junior Manager -Deviation Management and Manufacturing Investigations job posting and their answers.

👍We hope this helps in giving you a rough idea as to how to prepare for the interview for this specific role. Good luck!

  1. Can you provide an example of a deviation you have encountered in your previous work and how you approached the investigation process? How did you identify the root cause and propose appropriate CAPA? Answer: In a previous role, I encountered a deviation related to a manufacturing process. I initiated the investigation by gathering relevant data, conducting interviews, and analyzing process parameters. Through a systematic root cause analysis, I identified the root cause as a calibration issue with a critical equipment. To prevent reoccurrence, I proposed a CAPA that involved recalibration procedures and periodic equipment maintenance. The implementation of these measures successfully addressed the deviation and improved the process reliability.
  2. How familiar are you with GMP investigations and the use of Root Cause Analysis (RCA) tools? Can you share an example of how you have applied RCA in resolving an issue? Answer: I have extensive experience in conducting GMP investigations and utilizing Root Cause Analysis tools. In a previous project, we faced a recurring out-of-specification (OOS) result. Through a thorough RCA process, we identified the root cause as a contamination issue during a specific step in the manufacturing process. We implemented corrective actions, including improved cleaning procedures and enhanced monitoring of critical process parameters. This led to a significant reduction in OOS occurrences and enhanced overall product quality.
  3. How do you approach communication and conflict management in cross-functional teams? Can you provide an example of a situation where you effectively resolved a conflict within a team? Answer: Communication and conflict management are vital in cross-functional teams. In a previous project, there was a disagreement between team members regarding the implementation of a new process. I facilitated open and constructive discussions, allowing each member to express their concerns and viewpoints. Through active listening and fostering a collaborative environment, we reached a consensus by finding a middle ground that addressed everyone’s concerns while aligning with project objectives. This approach not only resolved the conflict but also strengthened team dynamics.
  4. Can you explain your understanding of Risk Management in the context of biologics operations? How have you applied risk mitigation actions (CAPA) in your previous work? Answer: Risk Management in biologics operations involves identifying, assessing, and mitigating risks to ensure product quality and patient safety. I have a solid understanding of risk management principles and have applied them in my previous work. For example, in a process improvement project, I conducted a thorough risk assessment by analyzing critical process steps and potential failure modes. Based on the assessment, I proposed and implemented risk mitigation actions, such as enhanced process controls, additional monitoring points, and operator training. These measures effectively reduced risks and enhanced process reliability.
  5. How do you ensure timely tracking of operational and compliance metrics in manufacturing operations? Can you provide an example of how you have utilized metrics for management reporting? Answer: Timely tracking of operational and compliance metrics is crucial for manufacturing operations. In my previous role, I established a robust monitoring system that captured relevant data and key performance indicators. I regularly updated and analyzed these metrics to identify trends, areas of improvement, and compliance gaps. For management reporting, I prepared concise reports that highlighted the key findings, deviations, and progress towards objectives. These reports provided valuable insights to management, enabling informed decision-making and proactive corrective actions.

Note: The answers provided here are for reference purposes and can be tailored based on the candidate’s actual experience and expertise.

About Syngene

Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status about public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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