• Sr Research Assistant, R&D - F&D Jobs in Ahmedabad,India

  • Baxter India Pvt Ltd

Job Description:

Execution of development trials
Compilation & evaluation of the development & stability data
Ensuring development trails to be performed as per QBD approach
Prepare the technical documents eg MFR, PDR, PDLM documents, Protocols & Reports
Provide required information for meetings with CFTs (Analytical, Regulatory, PSM, Quality, manufacturing, CMO, Project management) for on time project delivery
Provide required information for meetings with CMOs CROs & contract Labs for on time project delivery
Support for successful Technology transfer of Drug products
Support in execution of stability batches in Baxter sites & CMO
Support for Process validation and commercial batches
Technology transfer documents review of Products developed by CRO as per regulatory requirement
To review engineering batch & stability batch documents
Collection of the Stability batch data and review for trending
Review of Artworks
API, Raw material, packing material & Product specifications preparation & review of developmental products & commercial products Raw material and packing material specifications for the regulatory filing, CMO & for manufacturing plant
Perform the required activities for remediation projects to fulfill the Regulatory commitments/OOS/Project CCNs/CAPA/Product nature and criticality
Perform the required activities to fulfil the regulatory submission & query requirements
Prepare the reports to be provided for regulatory response
Self-Knowledge enhancement
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 for market complaint related activities
To possess and be updated on product submission and knowledge in regulatory market, current guidelines ie ICH, US-FDA, MHRA, EMEA etc
To identify & make available the necessary required resources or infrastructure or instruments to carry-out the day-to-day functions And ensure entire documentation related to formulation development & execution of batch
To assist Manager & Department Head in investigation for complaints and deviations To analyze investigation done by Executive, to suggest any further actions required, to conclude root cause and to seek approval of Corrective and Preventive Action (CAPA) from Department Head
To prepare change control and ensure timely closure of the same
Support & coordination with CMOs for successful technology transfer
Ensuring Lab equipment, instruments, documentation & Warehouse compliance
Preparation of SOPs
Documenting experiments in ELN
Identification & request of New Equipments/Instruments for projects in upcoming portfolio & continuous improvement of Development Lab
To adopt & follow the Global Quality procedures
To identify the safety hazards & perform the HIRA in coordinates with EHS safety practices at place

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

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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_TTAbaxtercom and let us know the nature of your request along with your contact information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 08th Apr 2020

Key Skills:

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