Job
Description
This is where
your work makes a difference.At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.Here, you will find more than just a jobyou will find purpose and pride.Essential Responsibilities:
- To lead and manage a team involved in method validation, method transfer and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilutions studies, RLD Characterization etc.) for 505b (2) and generic ANDAs.
- Play a lead role in resolution of the challenges faced during method validation & method transfer of new products from R&D to the Manufacturing sites
- To support the regulatory team for filing and query responses from analytical function
- Understand and ensure cGLP within ADL GMP function
- To provide support to the manufacturing plant during Quality inspections carried out by the regulatory agencies
- Responsible for timely closure of LIR, NCR, CCN, CAPA and to ensure the implementation of appropriate Corrective and Preventive action wherever required
- To ensure compliance to Pharmacopoeia update in timely manner
- Provide coaching, mentoring and development of each member of the team for execution of their responsibilities and in their own personal development
- Collaborate with external partners (CRO/CMO) to ensure successful execution of analytical testing wherever required
- Collaborate with cross functional team members i.e., project management, Regulatory Affairs, Formulation development, manufacturing, and quality control for smooth execution of projects from analytical perspective
Skills Required:
- Knowledge of Analytical method validation, method transfer, Pharmacopoeia compliance, cGLP and good documentation practices
- Sound understanding of the analytical techniques and good learning agility
- Writing and computer skills relevant to recording of data as well as generating technical protocols & reports and presentations to communicate with internal and external stake holders
- Coordination and relationship management and ability to work in multicultural environment
- Effective communication skills & team management
- Understanding of the latest quality and regulatory requirement
- Good team player and ability to effectively delegate the responsibility to the team members as per the requirement to ensure timely delivery of projects
- Comfortable in taking autonomous actions and decisions
- Working knowledge of cGLP requirements and basic knowledge of working principles of Cross Functional departments
- Communicates well across functional areas and large groups
- Demonstrates critical thinking skills in problem solving and decision making
- Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
- Has good interpersonal skills and works collaboratively in an effective manner to achieve objectives
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.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.
