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Executive - FRD Non-Orals

2 weeks ago

Vadodara, Gujarat, India SUN PHARMA Full time

Job Title
Executive – FRD Non-Orals

Business Unit
R&D1 Regulatory Affairs

Job Grade
G12A

Location
Baroda

At Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."

Key Responsibilities

  • Experience in Formulation R&D product development with experience in injectable product development in Novel drug delivery systems/Lyophilized product/Solution product.
  • To do literature search relevant to projects requirement and understanding of Regulatory guidance.
  • To procure raw materials (API/excipients), packaging materials and Reference product in consultation with packaging/purchase department.
  • To prepare request application for Testing/analysis license for new product/Reference product.
  • To design, conduct pre-formulation and formulation developmental experiments with QbD approach and to enter the details about drug product manufacturing experiments in Lab Notebook.
  • To prepare TR/IOM for the respective API/Excipients/product sample analysis.
  • To prepare product development/stability study protocols and reports, prepare SOPs for related laboratory equipment/instrument and maintain critical data records for regulatory audits.
  • To prepare document for Technology Transfer like sheet II, Master Formula, Risk assessment based upon CPP & CQA, FMEA and SDS.
  • Group work for lab management, handling instrument, common group activities and co-ordination with cross functional teams for handling projects issue.
  • To support cross functional activities at plant for Scale- up/ Exhibit batches/commercial batches and new assignments.
  • Preparation of Product development report (PDR), Risk assessment reports and do compilation of project issues.
  • To comply with the internal quality system while performing any activity.

Travel Estimate
NA

Job Requirements
Educational Qualification
Graduate : M.Pharm

Experience
Tenure : 2-4 years

Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together

Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).