Research Associate II

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Job title: Research Associate II

Company: Baxter

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. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s 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 lives—where your purpose accelerates our mission.

MANAGEMENT

  • Manage Reference standard documentation in adherence to compliance, Quality & Regulatory requirements
  • Assure specification and test methods are complied to USP, EP and other monographs where applicable
  • Manage QMS activities like change control, Incident, Deviation etc
  • Works transversally with cross-functional teams consisting of Compendial group, Quality Assurance Team, and External Partner
  • Provide training and supervision to junior members within the discipline

EXPERTISE

  • Preparation & Review of documents like Protocols, Reports for Familiarization, Validation & Qualification studies
  • Evaluation/review of Characterization & CSU studies of Reference standards to ensure compliance with respect to Quality requirements
  • Comply scientific data and interpret results in a clear, concise report
  • Assess, translate, and implement new regulation requirements into Reference Standard Program
  • Responsible for issuance of test methods (e.g., MOP methods / RSMS)
  • Able to document complex design and technical tasks, integrating information from a variety of disciplines
  • Adhere to the Quality System, understand potential impact and apply applicable corporate, divisional and departmental procedures as relevant
  • Considering usage of Reference Standards, the scope of understanding should cover Raw materials, API, Finished products development of robust and efficient analytical methods
  • Validation according to the business and regulatory needs
  • Involve in transfer of test methods to relevant partners
  • Should have sound knowledge in OOS/OOT and capable of independently handling NCR
  • Should have good knowledge in project management
  • Review and creation of analytical document in line with ICH, USP and other regulatory requirements
  • Preparation of SOP’s related to RS-CSU program
  • Handling and review of QMS activities like Change control, Incident and Deviation etc
  • Responsible for handling LIMS activities for Reference standard Qualification and CSU testing as defined in the SOP
  • To follow cGMP, GDP, GLP, and Regulatory requirements

Qualification

  • Must demonstrate strong leadership
  • Must demonstrate strong decision-making skills
  • Must be able to develop strategic direction for the organization
  • Must be self-motivated, have excellent interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as project management tools
  • Demonstrated in-depth experience in method development and validation of HPLC, GC, KF, and titration methods
  • Possess relevant laboratory/technical/writing and computer skills
  • Ability to defend Reference Standard Quality processes, Quality documents including their scientific content in front of external auditors (USFDA….)
  • Possess a thorough understanding of compendial (USP, EP…) and ICH guidelines
  • Proven experience working with cross functional teams
  • Computer skills: Excellent knowledge in Word, Excel, Outlook & Power point

Education and Experience

MSc with 7 to 10 years experience in scientific writing, analytical documentation and method validation either in Quality Control or Quality Assurance department .

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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Expected salary:

Location: Bangalore, Karnataka

Job date: Sun, 12 Jun 2022 03:50:15 GMT

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