- Responsible for monitoring live and inactivated antigen bulk production in coordination with stage 2 production, QA ,QC , Pilot, Ware house and engineering departments.
- Responsible for receiving of eggs, Pre incubation and pre candling of eggs followed by inoculation, post candling, Chilling and harvesting of eggs.
- Responsible for verifying the live and inactivated antigen from stage 1 to stage 2 internal staff for bulk production of products.
- Responsible for preparing, Maintaining and documenting of all stage 1 batch manufacturing records through log books and Erp.
- Monitoring of contract employees activities and training them in stage 1 for internal support.
- Responsible for preparing and maintaining weekly/ monthly stage 1 production reports, antigen stock statement for PPIC (Production planning and inventory control) meetings.
- Responsible for raising deviations, change controls in coordination with QA if there is any deviations or changes in the production stage 1 process.
- Responsible for monitoring and raising equipment breakdown maintenance in coordination with engineering department.
- Responsible for authorization to draw RM and consumable materials from stores for all antigen production related activities.
- Responsible for creating awareness about GMP, identifying risks and hazards in production stage 1 activities.
- Adhere to all company policies, procedures, positive manufacturing practices, health and safety standards.
- Conduct physical stock verification and asset verification for Monthly Inventory Audit.
- Responsible for Conducting GMP related external and stock audits
Knowledge / Experience / Skills / Personal Attributes:
- Essential: Should have 2-4 Years of experience in bulk antigen production. Should have the knowledge of other department activity process. Should know local Language. Have to work individually.
- Desirable: Multilingual. Experience from pharma domain.
Education Qualification:
- Essential: B.Sc in Biotechnology/ Microbiology.
- Desirable / Preferred: M. Sc in Biotechnology/ Microbiology