Ensure local regulatory and GMP guidelines are being followed across all departments (QC, Formulation, Production etc.) at the site and external to the site, as applicable.
Prepare, review and/or approve and retain Master Formulation Record (MFR), Site Master File, Company Quality Manual, Company Quality Policy, Water Quality Manual, Quality Risk Management File, Validation Master Plan File, Master Copy of SOP, Master Copy of BMR/BPR, Water System Validation Protocol, process Validation Protocol.
Prepare, review and/or approve and retain formulation batch records, production batch records, batch deviations, master batch records, change controls etc.
Lead/support internal and external audits/inspections and prepare, review and retain Corrective and Preventive Action (CAPA).
Serve as the focal point for obtaining manufacturing/marketing license and for product recall, handling customer complaints and other related activities.
Assess new suppliers’ QA programs, as well as audit existing suppliers.
Design training materials and implement QA trainings for all relevant stakeholders.
Serve as the focal point for product design, formulations etc. as per applicable regulatory requirements.
Support in dispensing, sampling, line clearance and process validation and utilities.
Mentor and provide guidance to subordinates in the team.
Apply Instructions
Interested candidates can apply online or send their CV at hr@meerabiotech.com
This Job is expired. The Company is no longer accepting applications for this position.
Organization Summary
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.
