Alembic Pharmaceuticals looking for Senior Research Scientist - B.Pharm, M.Pharm Apply

Alembic Pharmaceuticals Limited's rich legacy spanning over a century in the Indian Pharma Industry. With a steadfast commitment to quality and innovation, we continue to make significant strides in the pharmaceutical sector. To fuel our growth aspirations, we are seeking dynamic and results-oriented individuals to join our Formulation Manufacturing units located near Vadodara, Gujarat.

Post : Senior Research Scientist - MS&T (Complex Injectables)

Job Description
• Responsible for MS&T Documentation related activities.
• Preparation, issuance and retrieval of standard operating procedure (SOP’s).
• Initiation of Vendor Qualification process.
• Responsible to Organize and Co-ordinate Training Activities, Preparation of documents and Maintenance of training records.
• Responsible for material code initiation.
• Assisting for NPI activities.
• Responsible to carry out other assignments delegated by the Head of the Department from time to time based on qualification, experience and training.
• Initiation and closure of Change Control from MS&T Department.
• Initiation of New Product introduction form for new products first time introduced at site.
• Execution of Scale up/ Trial/ Submission batches in-coordination with Cross Functional Teams.
• To review and provide technical inputs on product development report (PDR), Master formula card (MFC) and Technology transfer (TT) documents, etc.
• To prepare product process related risk assessment.
• To prepare protocols and reports for feasibility trials and scale-up batches.
• To prepare and review Batch manufacturing record (BMR) and Batch packaging record (BPR).
• To review Exhibit batches summary reports.
• To 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.
• To support regulatory filing by providing intended commercial batch manufacturing record (BMR), Batch packaging record (BPR) and stability evaluation summary.
• To support regulatory in getting Test license, Import license, No objection certificate (NOC) and Manufacturing license by providing the necessary documents related to product and process.
• To review and provide Critical process parameters (CPPs) and Critical quality attributes (CQA) as part of 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 Injectable is essential.

Job Location : Vadodara, Gujarat
Last Date : 30th June 2024