Baxter India has served its mission to save and sustain lives for more than 25 years. We are committed to engaging collaboratively with patients, healthcare professionals, the government, and healthcare organizations nationally. Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital, surgical, and pharmaceutical products.
- Vacancy details:
- Department: Injectable R&D Formulation Development
- Qualifications: M.Pharma in Any Specialization/Ph.D/Doctorate in Any Specialization
- Experience: 4-6 Years
Job Description: Greeting from Baxter Pharmaceutical Solutions.!!!!
- Important Details :
- Location: Ahmedabad
- Post of date:13/06/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Virtual
- Interview Rounds of Interview: HR
Walkin Interview Details:
Time and Venue
22nd June , 9.30 AM – 5.30 PM
Virtual walk-in drive
Contact – Arshav Thakkar
Quality:
To conduct development trials as per requirement.
To compile & evaluate the development & stability data.
To ensure development trials to be performed as per the Quality By Design (QBD) approach.
To ensure the development of Complex formulations like injectable emulsion.
To ensure the development of Formulations like 505b2.
To ensure Handling of complex instruments like High-pressure homogenizing, microfluidizers, In-line homogenizers, and Lyophilizers.
Participation in query response drafting & finalization.
Participation in complex product protocol & report review & finalization.
Review of technology transfer document and finalization.
Independent discussion with CMO, CRO, and other CFT groups like RA, PMT, PQ & Plant to conclude tasks on timely basis.
Adopt responsibilities of Lab readiness for visitors & surprise visits from auditors.
Participation in Knowledge sharing sessions for personal & company knowledge 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 the required information for meetings with cross-functional teams like Analytical, Regulatory, PSM, Product Quality manufacturing, Contract Manufacturing Organization (CMO), and Project management for on-time project delivery.
To provide the 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 plants & Contract Manufacturing Sites.
To review engineering batch & stability batch documents.
To collect the Stability batch data and review for trending and conduct a review of artworks.
To support the sub-department manager in reviewing the technology transfer documents for products developed by CRO & assess the documents that are in-line with QBD based approach & as per current regulatory requirements.
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 fulfill the regulatory submission & query requirements.
To prepare the reports to be provided for regulatory response.
To handle troubleshooting 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 the start of production.
To support External and Internal regulatory audits with respect to Manufacturing Processes.
To support market complaint-related activities.
To possess and be updated on product submission and knowledge in the regulatory market, current guidelines i.e. ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use).
Masters degree with 6-8 years of pharmaceutical experience.
Knowledge of Pre-formulation and 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.
