Job Responsibility: Lead, Fill Finish - Vaccines

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JOB RESPONSIBILITY

Name:                                                Department: Fill Finish Vaccines

Designation: Head Fill Finish                         Area/Lab/Section: Production

1.    General Instructions:

1.1.          Each individual shall undertake the said duties but has to work along with the team in order to assume collective responsibilities. Individual adventurism of any sort is not encouraged.

1.2.          Any deviation observed during discharge of official duties is to be reported to the superiors immediately.

1.3.          Any person working in shifts has the additional responsibility of briefing the personnel working in the next shift about the work done and that to be undertaken subsequently.

1.4.            Addition or deprivation of duties and responsibilities shall depend on the performance of the individual.

2.    Duties/Responsibilities:

2.1.          Responsible for ensuring that the product being manufactured meets the company’s standards, policies and practices.

2.2.          Organize formulation & filling of vaccines as per standard laid down standards both inhouse and GMP.

2.3.          Plan production as per the market demand and ensure that filling targets are met as per the plan.

2.4.          Ensure availability of the resources as per the production plan.

2.5.          Ensure proper procedures are laid down in the production plant as per the latest GMP and Product requirements.

2.6.          Ensure that all the occupational safety procedures are laid down and followed by the staff.

2.7.          To prepare shift schedules as a part of day to day production planning.

2.8.          To ensure that the process of washing, depyrogenation, sterilization, filling, optical testing, labelling, packaging and storage of finished product are performed as per the validated process or laid down standards.

2.9.          To review records of all the above processes along with reconciliations and recoveries.

2.10.       Transfer of QC cleared batches of vaccines to finished good stores.

2.11.       To keep record of the interventions performed during filling process and to strategise for minimizing unwarranted interventions.

2.12.       Review of batch production records and summary protocols of vaccines. Review all the logbooks/log sheets and record forms for their completeness.

2.13.       Make sure that all the processes used during the filling processes are validated. To ensure that the equipments used in entire production process are qualified.

2.14.       To ensure that all the instruments and controls equipments are calibrated as per the calibration schedule.

2.15.       To access training needs of production staff. To impart or arrange for all the trainings needed by production staff.

2.16.       To serve as technical expert and troubleshoot production related problems.

2.17.       To monitor the performance of production team.

2.18.       To ensure proper discipline and team building and take steps to motivate team members.

2.19.       To streamline complete production process with a view to increase efficiency of plant.

2.20.       To improve on the inspection findings by various agencies.

2.21.       To be a part of self-inspection and quality audit team.

2.22.       To ensure periodic health examinations of workers as per GMP requirements.

2.23.       To supervise the overall administration of the production unit.

2.24.       Assign job responsibilities to production staff.

2.25.        Undertake other duties as determined by superiors.

3.    Authorities:

3.1.          Authorize activities in each section of the product in department as per the production schedules.

3.2.          To authorize deployment and re-deployment of staff in the department to carryout various productive activities as per the requirement.

3.3.          Assessment and Appraisal of the technical skills of the staff working in the department.

3.4.          Authorize transfer of the finished products to the warehouse after due clearance from QA.

3.5.            To review non-conformation in various sections and documentation of the same and initiate compliance to procedure.

4.    Reporting:

4.1.            Report to plant head/ factory manager all the daily activities and plans.

Assigned By CMD                                                                                       

(Signature and Date)

         

                                                                                               

Jobholder

(Signature and Date)