04 Nov
|
Talental Consultings
|
India
04 Nov
Talental Consultings
India
Job Title: Junior Research Associate /Research Associate
Department: R&D;, NDDS
- Conduct comprehensive literature reviews and patent searches to identify non-infringing and potentially patentable technologies.
- Perform pre-formulation studies and process feasibility evaluations for the development of novel drug products.
- Manufacture feasibility and prototype batches and coordinate with the Analytical Department for sample submission and evaluation.
- Execute batch manufacturing activities as per instructions from supervisors and ensure accurate documentation in laboratory notebooks and equipment logbooks.
- Manage the receipt, storage, handling, utilization, and documentation of reference products in compliance with internal procedures.
- Maintain inventory records of critical raw materials and active pharmaceutical ingredients (APIs), including tracking their usage and consumption.
- Ensure timely disposal of expired APIs, raw materials, and feasibility batches in accordance with approved SOPs, while maintaining proper records.
- Perform and monitor stability studies of prototype batches as per approved protocols and schedules.
- Support process optimization activities at the R&D; scale to improve product performance and manufacturability.
- Ensure compliance with Valuable Documentation Practices (GDP) by accurately recording all critical observations, process parameters, and manufacturing activities.
- Support the preparation of Product Development Reports (PDRs), Technology Transfer documents, and other technical documentation related to product development.
- Compile analytical data, interpret results, and prepare technical presentations and reports for internal review and decision-making.
- Oversee day-to-day laboratory operations, housekeeping, inventory management, and overall laboratory efficiency.
- Prepare, review, and maintain SOPs or equipment & instruments, and maintain departmental training records in close collaboration with Quality Assurance (QA) team to ensure timely training and compliance for all personnel.
- Coordinate calibration activities for analytical balances and processing equipment and coordinate with external vendors for annual maintenance and servicing of laboratory instruments, machinery and standard weights.
📌 Sr. Officer - R&D NDDS (India)
🏢 Talental Consultings
📍 India