Biological E - Manager/Sr Manager - B&F

Job Responsibilities

- To plan the Operations of Blending Suite- IV to meet the schedules as per the requirement.

- To ensure execution of Blending Suite- IV of blended batches / ready to fill bulk as per the requirements.

- To coordinate with inter-departments for the smooth functioning of the Blending Suite- IV activities.

- To maintain discipline in the Blending Suite- IV department.

- Monitoring of Lyophilization process related operations.

- Execution of Process and Cleaning Validations.

- Coordinating QA Validation team to perform equipment qualification.

- To manage men, machine and material for the optimum output as per the requirement.

- To ensure execution of process and cleaning validation.

- To ensure all cGMP activities and housekeeping activities are maintained in the critical operations / areas.

- To ensure that all the documents are as per the Good Documentation Practices laid down by Quality Assurance.

- To ensure all the staffs are trained and routine activities are carried as per the procedure in Blending Suite -1V department.

- To ensure that the stocks of all the primary and secondary materials are maintained with reconciliation and destruction records.

- Interaction with Q.A, Q.C, Engineering, Materials, Warehouse and HR.

- Review of SOPs and Protocols.

- Follow up for Internal and External audits.

- Practice and implementation of Environmental Management System and Occupational Health and Safety Management System.

- To maintain the stock of all primary and secondary material with reconciliation of materials after batch completion and maintaining the destruction records.

Technical Requirements:

- Hands on experience towards commissioning and qualification of clean rooms & Equipment as per GMP requirements.

- Sound experience towards formulation of live and non-live vaccines.

Key Personal Competencies:

- Should have excellent people management skills

- Experienced in developmental and clinical batches execution in a pilot plant.

- Cost estimation and controlling for a developmental trail batches