MSc, MTech Biotech QC Senior Executive Job at Syngene, Apply Online

Syngene QC Job Opening For MSc, MTech Biotech – Apply Online

Syngene QC Job Opening For MSc, MTech Biotech – Apply Online. MSc, MTech Biotechnology Job in Syngene, Bangalore. Syngene is hiring Biotechnology candidates for the QC Senior Executive job.

The five possible interview questions that can be asked in the technical round for the QC Senior Executive position, along with their answers are posted below:

QC Senior Executive

Job ID: 54165

JOB DESCRIPTION

Job Location: Bangalore, Biocon Park

Designation: Senior Executive

Department: Quality Control -Biologics

About Syngene

Incorporated in 1993, 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 around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. 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.

Job Description:

• To handle the Inprocess and Finished products analysis in shifts
• To perform the analysis of Stability samples.
• To handle the calibration of QC instruments/Equipment.
• To ensure the completion of trainings allotted in time and support the team lead for achieving the deliverables.
• Adhere to the SOP/IOP and perform the analytical activities.
• Adhere to the good laboratory practice and compliance.
• Ensure error free analysis and documentation.
• Co-Ordinate with external vendors for ensuring timely calibration and PM activities.
• To ensure storage chambers are maintained at set t temperature limits and take timely action in case of any excursions.
• To ensure the instrument/equipment are in calibrated state.
• Ensure the breakdowns if any are rectified in time and instrument is made up and running within shortest possible time in co-ordination with service provider.
• Ensuring all time audit readiness and preparation prior to audits.
• Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
• To support any other activity allotted by the team lead.

Key Responsibilities:  

• Operating in shift and ensuring release of Inprcoess/Finished product samples within TAT and by adhering to compliance norms.
• Ensuring the calibration of instruments and handling breakdown in coordination with vendor.
• Adhering to good laboratory and analytical procedures.

Educational Qualification: Bachelor/Master of Science / Master of Technology -Biotechnology/Bioprocess Engineering

Technical/Functional Skills:

• Entry level Knowledge on Biologics Manufacturing and testing compliance requirements.
• Good communication
• Co-Operation with team leads.

Experience: 3-6 years of experience in Biopharma manufacturing/testing/ compliance/ Quality control.

Behavioural Skills:

• Aggressive but assertive on task completion.
• Personal integrity and good attitude.

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 with regard to 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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Here are five possible interview questions that can be asked in the technical round for the QC Senior Executive position, along with their answers:

1. Can you describe your experience in handling in-process and finished product analysis in a quality control (QC) setting? How do you ensure accurate and reliable analysis?
   • Answer: In my previous role, I have been responsible for performing in-process and finished product analysis in a QC environment. To ensure accurate and reliable analysis, I strictly adhere to standard operating procedures (SOPs) and good laboratory practices. I conduct thorough instrument calibrations, maintain proper documentation, and follow validated analytical methods. Additionally, I implement quality control measures such as running appropriate controls and performing data verification to ensure accurate and reliable results.
2. How familiar are you with stability sample analysis? Can you explain the key considerations and challenges involved in this type of analysis?
   • Answer: I have experience in analyzing stability samples to assess the product’s shelf life and quality over time. Key considerations include selecting appropriate storage conditions, conducting periodic sampling, and performing various tests to evaluate the product’s stability. Challenges can include degradation of the sample, maintaining consistent storage conditions, and designing a robust testing plan. I have overcome these challenges by carefully monitoring storage conditions, using validated analytical methods, and collaborating with the team to develop suitable testing protocols.
3. Have you handled instrument calibration and troubleshooting in a QC laboratory? Can you provide examples of instruments you have worked with and how you ensured their reliable performance?
   • Answer: Yes, I have hands-on experience in instrument calibration and troubleshooting. I have worked with instruments such as HPLC, spectrophotometers, pH meters, and balances. I ensure reliable instrument performance by conducting routine calibrations, following manufacturer guidelines, and tracking calibration schedules. In case of instrument breakdowns, I promptly coordinate with the service provider for quick resolution and maintain proper documentation for audit purposes.
4. How do you ensure compliance with good laboratory practices and analytical procedures in a QC environment? Can you describe any specific challenges you have encountered and how you addressed them?
   • Answer: Compliance with good laboratory practices (GLP) and analytical procedures is vital in a QC setting. I maintain strict adherence to GLP by following SOPs, recording accurate and comprehensive documentation, and regularly participating in internal audits. One challenge I have encountered is managing multiple projects and maintaining the timeliness of analysis while ensuring compliance. To address this, I prioritize tasks, effectively communicate with the team, and maintain a systematic approach to documentation and workflow management.
5. Can you provide examples of your experience in coordinating with external vendors for instrument calibration and preventive maintenance activities? How do you ensure timely and effective coordination?
   • Answer: In my previous role, I have collaborated with external vendors for instrument calibration and preventive maintenance activities. I have established effective communication channels to ensure timely scheduling of calibrations and preventive maintenance tasks. I regularly follow up with vendors, maintain records of service schedules, and coordinate closely to minimize instrument downtime. Additionally, I ensure that all calibration certificates and service reports are appropriately documented and filed for audit readiness.

Please note that these are sample interview questions, and the actual questions asked in the interview may vary depending on the interviewer and the specific requirements of the job position.

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