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Position: Senior Research Scientist – MS&T (Complex Injectables)

Job Description:

  • Responsible for MS&T Documentation related activities.
  • Preparation, issuance, and retrieval of standard operating procedures (SOPs).
  • Initiation of Vendor Qualification process.
  • Organize and coordinate training activities, preparation of documents, and maintenance of training records.
  • Material code initiation.
  • Assist in NPI activities.
  • Carry out assignments delegated by the Head of the Department based on qualification, experience, and training.
  • Initiation and closure of Change Control from the MS&T Department.
  • Initiate New Product Introduction forms for new products.
  • Execute Scale-up, Trial, and Submission batches in coordination with Cross Functional Teams.
  • Review and provide technical inputs on product development reports (PDR), Master formula cards (MFC), and Technology transfer (TT) documents.
  • Prepare product process-related risk assessments.
  • Prepare protocols and reports for feasibility trials and scale-up batches.
  • Prepare and review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
  • Review Exhibit batch summary reports.
  • Support Process Validation (PV) batches and provide technical inputs in process validation documents such as Critical Process Parameters (CPPs), Critical Quality Attributes (CQA), and controls.
  • Support regulatory filing by providing intended commercial batch manufacturing records (BMR), Batch Packaging Records (BPR), and stability evaluation summaries.
  • Support regulatory processes by providing necessary documents for product and process-related licenses and certificates.
  • Review and provide CPPs and CQAs as part of the annual product review.

Candidate Profile:

  • Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) with a specialization in Pharmaceutics or Pharmaceutical Technology.
  • 8-12 years of Technology Transfer experience within the pharmaceutical industry.
  • Prior experience in Injectables is essential.

Job Location: Vadodara, Gujarat

Application Deadline: 30th June 2024

Interested candidates can share their CV at msnt@alembic.co.in.

Alembic Pharmaceuticals Hiring Senior Research Scientist B.Pharm / M.Pharm

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