Production Executive

Job Description

Key Responsibilities: Microbiological Production & Fermentation: Operate, monitor, and optimize fermenters to ensure optimal conditions for bacterial culture growth and antigen production. Oversee bacterial strain maintenance, growth, and antigen extraction processes. Ensure aseptic handling techniques to prevent contamination and maintain product integrity. Compliance & Documentation: Ensure strict adherence to ISO 13485:2016, GMP, and MDR 2017 regulatory standards. Maintain accurate Batch Production Records (BPRs) and Standard Operating Procedures (SOPs). Document and analyze production data to improve efficiency and maintain consistency. Quality Control & Assurance: Monitor production parameters and ensure batch-to-batch consistency in antigen production. Work closely with the Quality Control (QC) and Quality Assurance (QA) teams to address deviations and implement corrective actions. Conduct in-process testing to verify antigen concentration, purity, and stability. Collaboration & Process Improvement: Coordinate with R&D and QA teams for process validation and improvements. Identify and implement process optimization strategies to enhance production efficiency and quality. Train and supervise production staff in microbiological techniques and compliance protocols. Qualifications & Skills: Education: Masters Degree (M.Sc.) in Microbiology, Biotechnology, or related field. Bachelors Degree (B.Sc.) in Microbiology, Biotechnology, or related field with relevant experience.