Jobs at Biocon limited

Executive – API Production (Fermentation), Biocon Limited, Small Molecule VIZ SEZ Production, India.

The role covers API production fermentation operations, including shop floor supervision, aseptic handling, documentation and compliance with GMP, quality and EHS requirements.

• Adherence to Standard Operating Procedures, product specifications.
• Calibration and Handling of pH, conductivity, ammonia meter and weighing instruments in production.
• Monitoring and control of specific production operations, Product handling, product identification.
• Monitoring and maintenance of raw material / Product inventory in co-ordination with superiors.
• Responsible for dispensing of Raw Material storage / in process activities / inspection.
• Active role on Fermenters & NDVs SIP & CIP activities.
• Seed Inoculations and line steaming activities.
• To supervise shift activities on shop floor aseptically handlings.
• Preparation and Review of BMRs/ ECCS/ CKLs and log sheets.
• Preparation and Review of SOPs, EOPs, IOPs etc.
• Sound knowledge on Lab equipment's like Autoclave, BSC Cabinet, Incubator Shakers, pH meter, Centrifuge etc.
• Handling on filter integrity test and filters log maintenance.
• Achieving the production targets.
• Production batch & raw material planning for production.
• Procurement of the raw materials from the Stores through the Material Requisition Slip.
• Planning of personnel shift schedule.
• Maintenance of Production equipment in coordination with Engineering and maintenance Department.
• Plant and Machinery modifications or improvements.
• Adherence to Good manufacturing practices.
• Reporting of non-conformities and adherence and initiation to the corrective / preventive actions with quality assurance, senior members of production department and other concerned departments in specific areas of operation.
• Authorized to raise and review the Change controls and Deviation Reports.
• Maintenance of production related documents and quality records.
• Imparting training to the below hierarchy level on SOP's, EOP's, IOP's, and Process related aspects to maintain quality and consistency in Production.
• Adherence to safety, Health and Environment norms and pollution control.
• To follow the established procedures and policies of the company pertaining to EHS management system.
• To understand the implications of not following the defined procedures with respect to EHS.
• To effectively participate in the preparation of AIM and HIRA register.
• Co-ordination for Preparation of HAZOP study.
• Handling of e-BMR/BMR and Inventory Management System (SAP) activities.
• Initiation of corrective and preventive actions against non-conformances.
• Overall coordination with other departments related to production activities.
• Adherence to Quality Policy and Quality Management System.
• To coordinate with QA for all the validation, qualification and Audit preparedness.
• Identified as authorized personnel for Visual inspection and swab sampling activities.
• Sound knowledge to Operate Fermenters from 100L to 100kL capacity and Nutrient Dosing Vessels from 200L to 12KL capacity and Media Preparation Vessels from 500L to 20kL capacity and 10kL CIP tanks.
• Review of batch reports and Involvements on productivity improvements and batch failure investigations.

• Required Education Qualification: B.Sc
• Required Experience: 1 - 10 years