Executive / Sr. Executive - Formulation Development

3 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Aizant Drug Research Solutions Pvt. Ltd.

time outline icon Hyderabad, Telangana, India

Posted on 25-10-2021

188 Views

1 Vacancy

Description

Perform formulation development activities to ensure projects are delivered with agreed target product profiles (TPP) and timelines. Perform all related activities in coordination and consultation with the team leader.
Actively participate in the literature search and preparation of formulation development strategy.
Coordinating with cross functional departments like Research and Development (R&D), Regulatory Affairs (RA), Quality Assurance (QA), Production Quality Control, Warehouse, Engineering, Purchase and Human Resources Departments for routine day to day activities to resolve the issue / problem with proper time management.
To ensure compliance to Good Laboratory Practice and Good Document Practice (laboratory Note book, Log books, Standard Operating Procedures) while working on a given project.
Involve in the execution of batches supporting drug product development as per the project requirement.
Ensure the control of documents, (Monitoring Issue / Archival / Retrieval).
Review of lab note books, review and interpretation of analytical results and stability data.
Prepare and review of department Standard Operating Procedures (SOPs)/Guidelines/Operating instructions. Conducting training on the departmental SOPs/ Guidelines/ Operating Instructions.
Coordination with equipment / instrument suppliers for drawings and qualification documents.
Preparation and review of master formula card (MFC), packaging data sheet (PDS), scale up protocol, process evaluation plan, and exhibit batch protocols, stability protocol.
Prepare product development reports, summary reports for exhibit and process evaluation batches, and ensure phase/stage wise product development reports (PDRs) are in place.
Initiation of review of the specifications for raw material, packaging material, in-process and finished product.
Conduct training sessions for both analytical and formulation team members on the advances in drug product development.
Calibration of Instrument/equipment pertaining to the department.
Coordinate with QA department for getting forms and logbooks.
Any other responsibility assigned by supervisor.