Maintain a record of all raw materials i.e., Active Pharmaceutical Ingredients (API) and excipients received in R&D department.
Send requisition to Quality Control (QC) department for sampling of raw materials for their analysis.
Conduct literature review of APIs, excipients and their compatibility in collaboration with QC department.
Prepare Batch Processing and Packaging Record (BPPR) and modify (as needed) to develop the optimum formulation.
Collaborate with the QC department to ensure product quality.
Support in ensuring local (and other applicable) regulatory and GMP requirements are adhered to for various activities in the R&D department.
Maintain record of all the work to ensure compliance of product submissions as per regulatory requirements.
Prepare, review and retain technical documents i.e., BPPR, Product Specification, Summary of Product Characteristics and other relevant documents for the regulatory filling purposes to obtain a manufacturing license.
Supervise all the activities carried out in the R&D department i.e., Dispensing, Granulation, Compression, Coating, Change Over, etc.
Keep oneself updated with current regulations and technical knowledge.
Provide input on technical feasibility and resource required for any project related to formulation and development.
Prepare and monitor department monthly/quarterly/annual work plan, key performance indicators and ensure these are reported accurately and on time.
Prepare, review and retain documents for technology transfer to the production department.
Mentor and provide guidance to the subordinates in the team.
Interested candidates can apply online or send their CV at firstname.lastname@example.org
Meera Biotech, driven by Quality, Efficiency and Innovation, is an upcoming pharmaceutical company which seeks to become the leader in pharmaceutical industry in Nepal with a short-to-mid-term goal of establishing itself as a high quality brand in the domestic market and with the long term goal of exporting its products to other countries.