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.