Research Associate, FRD - Injectables

Job Summary

To plan and execute the product developmental activities and to ensure proper documentation, follow  procedures as per the requirements of Apotex Research Pvt. Ltd.

Job Responsibilities

• Conduct literature survey and compile the scientific findings for allocated projects.
• Plan and perform the Pre-formulation studies, and innovator product characterization
• Planning, procurement and execution of product development activities of assigned dosage forms
• Responsible to submit the samples to analytical team for evaluation and coordinate to get the data on time.
• Preparation of study protocols and reports and compilation of analytical data
• Support to execute the studies planned in external lab and monitor the execution quality.
• Conduct formula and process optimization studies for allocated projects and must be a team player.
• Prepare stability protocols as per regulatory guidelines, execute the studies and compile the results
• Execution of tech-transfer and monitoring of scale-up/exhibit/process validation batches at plant
• Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting
• Support for documentation of development reports and continuous improvement procedures.
• Prepare and assist in finalization of instrument/equipment operating procedures.
• Perform daily/monthly calibrations of Lab Instruments and support for internal audits/trainings.
• Follow departmental SOPs to carryout the product development activities
• Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook
• Responsible to raise PR for procurement of API, raw materials, and packing materials for development batches and receipt of same
• Report to next level manager regarding day to day activities.

Take up any other work as allotted per Department requirements

Job Requirements

• • Education
    • M Pharma in Pharmaceutics./ Pharma/ B Tech
  • Knowledge, Skills and Abilities
    • Experience in handling of Liquid, Injectable, ophthalmic dosage forms is a must.
    • Effective command over verbal and written communication with good interpersonnel skills.
    • Proficient in MS office tools.
    • Knowledge on preparation of various documents like SOPs, formats, protocols, reports etc.
    • Having well versed knowledge on regulatory guidelines
    • Experience in handling of Liquid, Injectable, ophthalmic dosage forms is a must.
    • Able to priortise the task, best in effective planning of work activities to meet the timelines.
    • Must have knowledge on handling of machinery/equipment related to parenteral dosage form
  • Experience
    • Minimum 3 to 6 years of experience in Injectable and Ophthalmic formulation development.