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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)
