Research Associate Job at Baxter For Pharma Candidates
Research Associate Job at Baxter For Pharma Candidates. Baxter a global healthcare company is now Hiring Research Associate I for Product Quality. Interested candidates can check out the details below and Apply Online.
Job Title: Research Associate I
Requisition ID: JR – 101731
Location: Ahmedabad, Gujarat, India
Job Category: Quality
Job Description :
Calibration & Maintenance
- Expertise in Calibration & maintenance wrt to various equipment’s & Instruments in terms of analytical, formulation and engineering of R&D, Pharma.
- Expected to be technically strong in terms of carrying out the calibrations & maintenance as well as supervise the same with 3rd party vendors.
- Well aware of the National Standards, NABL requirements, Regulatory requirements in terms of Calibration & Maintenance.
- Should be well aware of ISO13485 & 172085 in terms of applicability wrt to Metrology.
- End to end handling of the calibration & maintenance lifecycle & should be well versed to use the electronic platforms for the same including troubleshooting.
- Vendor management – to interact with the suppliers & third parties for completion of calibration activities within the scheduled timelines.
- Proactive in organizing the activities as per the schedule by coordinating with stakeholders as well as vendors.
- Budgeting & optimizing the Calibration & Maintenance costs.
- Working on the CAPEX projects & driving the continuous improvement initiatives.
Qualification & Validations
- To be well versed & have hands on experience in end to end qualification process.
- To be able to review & provide technical inputs for the QP, IQ,OQ,PQ & DQ.
- To be able to write the test scripts for the qualifications if required.
- To be a part of the CSV for supporting the IT team
Environmental Monitoring ( EMS ) wrt lab condition like temperature, RH
- Should be familiarized with the Operation & Maintenance of EMS.
- Should have a troubleshooting knowledge on EMS.
- Should be experienced in Temperature Mapping.
Other requirements
- Should possess strong skills in terms of writing, reviewing & approving GMP documents such as protocols, tests, SOP’s.
- Should be well versed with Quality requirements such as NCR & CAPA management with investigations & root cause analysis knowledge, Change Management (would be an advantage if knows Trackwise tool).
- Should be able to manage the team as well as vendors & stakeholders
- Strong awareness & experience required in GMP, GDP, DI, GLP ( GxP), 21 CFR part 11 compliance.
- Should be aware of managing Projects.
- Strong team player, interpersonal, soft skills, communication & organizational skills required.
- Should know MS-Office tools, Track wise, Blue Mountain (or similar calibration software platform)
- Should have problem solving capabilities & solutions based approach.
- Should be able to think out of box & come up with alternatives while handling any issues.
- Should have good networking skills (with own team members, vendors & cross functional teams ).
- Should be able to face & be the front face in the audits – internal & external.
- Should be able to identify the issues & gaps & work towards continual improvement.
Educational & Experience
- Experience of approx. 8 – 10 years, educational background preferably Pharma or instrumentation postgraduate having good experience on instrumentation and its related investigation handling ability.
- Relevant certifications would be a plus.
- Should have an experience as a supervisor & managed teams/team member.
- Should be fluent in English – communication, Speaking & writing.
 Research Associate Job at Baxter. Here are interview questions and answers:
1. Question: Can you describe your experience in managing the calibration and maintenance of equipment in an R&D and pharmaceutical setting? How do you ensure compliance with national standards, NABL requirements, and relevant regulations?
Answer: Over the past 8-10 years, I have been extensively involved in managing calibration and maintenance activities in R&D and pharmaceutical environments. I ensure compliance with national standards, NABL requirements, and relevant regulations by staying updated with the latest guidelines and conducting regular internal audits. I have a thorough understanding of ISO13485 and 172085, which helps me apply the necessary metrology practices. Additionally, I closely supervise calibration processes with 3rd party vendors, maintaining a strict schedule and budget to optimize costs effectively.
2. Question: How do you approach end-to-end qualification processes, including QP, IQ, OQ, PQ, and DQ? Can you provide an example of a qualification project you successfully completed?
Answer: As a Research Associate, I am well-versed in end-to-end qualification processes. I begin by reviewing and providing technical inputs for qualification protocols (QP) and creating test scripts if required. For instance, in a recent qualification project for a new analytical instrument, I successfully executed IQ and OQ protocols, ensuring the equipment met the required performance standards. Subsequently, I oversaw the PQ and DQ phases, validating the instrument’s suitability for its intended purpose.
3. Question: Describe your experience with Environmental Monitoring Systems (EMS), particularly in maintaining lab conditions like temperature and humidity. How do you handle troubleshooting issues related to EMS?
 Answer: I have significant experience with Environmental Monitoring Systems, specifically in monitoring lab conditions such as temperature and humidity. I have expertise in the operation and maintenance of EMS, and when issues arise, I take a systematic troubleshooting approach to identify the root causes. In a recent case, I encountered a deviation in temperature mapping, and by conducting a thorough investigation, I discovered a faulty sensor, which was promptly replaced, ensuring accurate and reliable temperature monitoring.
4. Question: Can you share your experience in managing GMP documents, such as protocols, tests, and SOPs? How do you ensure compliance with quality requirements like NCR and CAPA management, along with investigations and root cause analysis?
 Answer: Throughout my career, I have been actively involved in writing, reviewing, and approving GMP documents, including protocols, tests, and SOPs. To ensure compliance with quality requirements, I have a robust system in place for Non-Conformance Reports (NCR) and Corrective and Preventive Action (CAPA) management. I lead investigations, employing root cause analysis methodologies to address issues proactively. I have experience using tools like Trackwise, which facilitates efficient change management and documentation control.
5. Question: In your previous role as a supervisor, how did you effectively manage teams and stakeholders while handling projects and ensuring GxP compliance?
 Answer: As a supervisor, I prioritize effective communication and collaboration with team members, stakeholders, and cross-functional teams. By fostering a supportive and inclusive environment, I motivate team members to perform at their best. I emphasize the significance of GxP compliance and conduct regular training sessions to keep everyone updated on the latest guidelines and practices. Additionally, I involve team members in project planning and decision-making, empowering them to take ownership of their roles and contribute to the success of the projects. In audits, both internal and external, I take the lead in representing the team, identifying areas for improvement, and driving continual improvement initiatives.
Note: The sample answers provided above are for illustrative purposes only. It’s essential to tailor your responses based on your actual experiences and achievements in your previous roles. Good luck with your interview!
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