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\xe2\x80\x94where your purpose accelerates our mission. Quality:

• To conduct development trials as per requirement.
• To compile & evaluate the development & stability data.
• To ensure development trails to be performed as per Quality By Design (QBD) approach.
• To ensure development of Complex formulation like injectable emulsion.
• To ensure development of Formulation like 505b2.
• To ensure Handling of complex instruments like High pressure homogenise, Microfluidizer, In-line homogenizer and Lyophilizer.
• Participation in query response drafting & finalization.
• Participation in complex products protocol & report review & finalization.
• Review of technology transfer document and finalization.
• Independent discussion with CMO, CRO, other CFT groups like RA, PMT, PQ & Plant to conclude task on timely basis.
• Adopt responsibilities of Lab readiness for visitor & surprise visit from auditors.
• Participation in Knowledge sharing sessions for personal & company knowlege improvement.
• Provide guidance to juniors to perform tasks on faster basis with maintaining quality of the system.
• To prepare the technical documents e.g. Master Formula Record (MFR), Product Development Report (PDR), Product Development Lifecycle Management (PDLM) documents, Protocols & Reports.
• To provide required information for meetings with cross functional teams like Analytical, Regulatory, PSM, Product Quality manufacturing, Contract Manufacturing Organization (CMO), Project management for on time project delivery.
• To provide required information for meetings with Contract Manufacturing Organizations (CMO), Contract Research Organizations (CRO) & contract Labs for on time project delivery.
• To support the execution of stability batches in Baxter sites & CMOs.
• To support Process validation and commercial batches.
• To provide support for successful technology transfer of drug products at manufacturing plant & Contract Manufacturing Sites.
• To review engineering batch & stability batch documents.
• To collect the Stability batch data and review for trending and conduct review of artworks.
• To support sub-department manager to review the technology transfer documents for products developed by CRO & assess the documents which are in-line with QBD based approach & as per current regulatory requirement.
• To perform the required activities for remediation projects to fulfill the regulatory commitments for Out of Specification or Project Change Control Notes or Corrective and Preventive Action or product nature and criticality.
• To perform the required activities to fulfil the regulatory submission & query requirements.
• To prepare the reports to be provided for regulatory response.
• To handle trouble shooting during exhibit and commercial batches with an ability to investigate any Out of Specification (OOS) or Out of Trend (OOT) results.
• To interact with the plant team and impart new product introduction prior to start of production.
• To support External and Internal regulatory audits with respect to Manufacturing Process.
• To support market complaint related activities.

To possess and be updated on product submission and knowledge in regulatory market, current guidelines i.e. ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use).

• Master\xe2\x80\x99s degree with 6-8 years of pharmaceutical experience.
• Knowledge of Pre-formulation, Formulation Process Development for Regulatory and Non-regulatory markets.
• Desired knowledge of R&D plant equipment, well versed with equipment qualification and validation, including packaging.
• Experience in working with CRO & CMO and managing external projects across the globe.
• 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.

Shows commitment and dedication and strives to be ahead of schedule. 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. 136500