Latest M Pharm job – Research Associate role at Dr. Reddy’s Laboratories – APPLY NOW
Designation : Research Associate – Process Science and Technology ( Drug Product)
Company : Dr. Reddy’s Laboratories
Department : Biologics
Open Positions : 01 (one)
Location : Bachupally, Hyderabad, Telangana, India
Education/Qualification : M Pharm
Job Description :
- Responsible for Product transfer, Technology Absorption, Process qualification activities for Biological products
- Responsible for Execution and Monitoring of Trial / Phase-I/III , Pre-validation / Process performance qualification batches for technology transfer of products, Continued process verification, Process simplification, machine change, batch size change and other routine Validation / Qualifications.
- Responsible to perform/review the investigations arising from incidents, out of specifications, out of trends, product failures, to identify the root cause and implement appropriate corrective and preventive actions.
- Process / Product Risk evaluation and recommendation on proposed changes.
- Co-ordination with Production, Quality Assurance, Regulatory Affair, Quality Control, Supply Chain Management & vendors for collection of data /reports.
- Preparation, Review and approval of following documents but not limited too,
- Trial batches/ Phase-I/Phase III/ Pre-validation/ Process performance qualification batches Protocols & Reports.
- Master Formula Record, Batch Manufacturing records, BOM for Raw Material, Packing material
- Equivalency Report, Technical and scale up evaluation Reports, Hold time Study Protocol and Reports.
Compilation and compliance to Technology transfer SOP Checklis
Skills : DP manufacturing and Technology transfer of Injectable Dosage forms (Liquid and Lyophilized) for Biologics
Years of experience required for Research Associate role at Dr. Reddy’s Laboratories :
- 6-12 yrs. of experience in the product development, tech transfer activities for biological molecules/ injectable products, knowledge of Aseptic manufacturing & filling operations.
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Here are some potential interview questions along with their answers for the Research Associate role at Dr. Reddy’s Laboratories :
1. Can you provide an overview of your experience in product transfer and technology absorption for biological products?
Answer: Certainly. I have around [X] years of experience in product development and technology transfer activities for biological molecules and injectable products. I have been involved in various stages of the process, including product transfer, process qualification, and technology absorption. My experience includes executing and monitoring trial and phase batches, performing process performance qualification, and ensuring the continued process verification. I have also been responsible for identifying and implementing corrective and preventive actions based on investigations arising from incidents, product failures, and out-of-specifications.
2. How have you coordinated with different departments such as Production, Quality Assurance, Regulatory Affairs, Quality Control, and Supply Chain Management during technology transfer projects?
Answer: Collaboration with cross-functional teams is crucial during technology transfer projects. I have successfully coordinated with Production to ensure seamless execution of trial batches and phase batches. I have worked closely with Quality Assurance to ensure compliance with regulatory standards and guidelines. Additionally, I’ve liaised with Regulatory Affairs to ensure the necessary documentation and approvals are obtained. Collaboration with Quality Control helped in evaluating the product’s quality and making data-driven decisions. Lastly, Supply Chain Management was consulted to gather essential data and reports for the technology transfer process.
3. Can you provide an example of a challenging incident or out-of-specification situation you’ve encountered during a technology transfer project and how you resolved it?
Answer: Certainly. During a technology transfer project, we encountered an out-of-specification situation with a critical parameter in the production process. I immediately initiated an investigation to identify the root cause. After thorough analysis, we discovered that the issue was related to a calibration error in one of the instruments. I collaborated with the relevant teams to rectify the calibration, retest the affected batches, and implemented corrective actions to prevent such incidents in the future. This experience emphasized the importance of stringent monitoring and quick problem-solving during technology transfer processes.
4. Could you explain your approach to evaluating process and product risks and providing recommendations for proposed changes?
Answer: Evaluating process and product risks is vital to ensure product quality and patient safety. I adopt a systematic approach by first identifying potential risks through a comprehensive risk assessment. This includes considering factors such as process complexity, raw material variability, and critical process parameters. Once risks are identified, I prioritize them based on severity and likelihood. For proposed changes, I thoroughly assess their potential impact on the process and product quality. I provide recommendations based on data-driven analysis, highlighting the advantages, disadvantages, and risk mitigation strategies associated with each change.
5. How do you ensure compliance with Technology Transfer SOP Checklists and relevant documentation during the transfer process?
Answer: Compliance with SOP Checklists and documentation is essential for a successful technology transfer. I ensure compliance by meticulously following established SOPs and protocols. I am thorough in preparing, reviewing, and approving documents such as batch manufacturing records, master formula records, and technical evaluation reports. Regular audits and quality checks are performed to confirm that all necessary documentation is accurate, up-to-date, and aligned with regulatory requirements. This approach ensures that the technology transfer process is executed smoothly and in accordance with industry standards.
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