Research Associate II, Design Quality
Research Associate II, Design Quality
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Job Description
This is where you save and sustain lives
At Baxter we are deeply connected by our mission. No matter your role at Baxter your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters products and therapies are found in almost every hospital worldwide in clinics and in the home. For over 85 years we have pioneered significant medical innovations that transform healthcare.
Together we create a place where we are happy successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.
Responsibilities:
Major responsibilities are as mentioned below but not limited to
- Review and approval of technical documents of GPRD which includes analytical and formulation documents.
- Perform tool based investigations for CMO R&D plant and contract labs to ensure compliance with cGxP regulations and guidelines.
- Review and approve QMS documents such as change controls investigations and audit reports in TrackWise.
- Handle market complaints and manage the quality management system (change control CAPA deviations OOS etc.).
- Coordinate with external/internal auditors and ensure timely closure of audit findings.
- Provide expert advice on cGxP regulations and guidelines.
- Prepare review and implement SOPs.
- Carry out internal quality audits of R&D lab and maintain Good Laboratory practices.
- Review and approval of risk assessments for commercial product support.
- Risk management human factor accelerated aging study pFMEA distribution study sterilization assurance etc. documents review.
- Monitor and evaluate the performance of process and analytical methods to identify any issues or deviations.
- Collaborate with other departments to ensure that all methods and procedures are compendial compliant.
- Represent subject matter expertise in the areas of process and Analytical (Validation Verification and Transfer) as a Quality SME internally and externally as needed.
- Compliance verification through GEMBA walks.
- Handling of SNCs (Supplier Notification of change).
- Review and approval of Packaging development documents and data along with procedures.
- Review and approval of registration and commercial stability data along with trend analysis.
Requirements:
- Master or Bachelors degree in Life Sciences Pharmaceutical Sciences or a related field.
- At least 8-15 years of experience in Quality Assurance or related field.
- In-depth knowledge and understanding of cGxP regulations and guidelines.
- Excellent communication and interpersonal skills.
- Strong technical knowledge investigational and problem-solving skills.
- Ability to work in a team environment.
- Proficient in Microsoft Office and other quality management systems.
- Proficiency in Microsoft Office and TrackWise8.
- Continual system improvement and cGxP mindset
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.
Required Experience:
IC
Employment Type
Full-Time
