Job Responsibility: Head Bulk Manufacturing

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JOB RESPONSIBILITY

Name:                                             Department: Bulk Manufacturing

Designation: Head Bulk Manufacturing           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.          To plan bulk production and formulation activities as per the market demand.

2.2.          To ensure availability of the resources as per the production plan.

2.3.          To ensure that all the batches are initiated only after the approval of QA Department and before initiating the batch schedule for batch manufacturing and sampling shall be approved by QA/QC department.

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

2.5.          To ensure proper procedures are laid down in the bulk production and formulation area as per the latest GMP and Product requirements.

2.6.          To ensure that the procedures are laid down for bio safety and containment in the bulk manufacturing plant. Proper procedural demarcation shall be maintained to avoid mix-up of any kind.

2.7.          To ensure that all the occupational safety procedures are laid down and followed by the staff.

2.8.          To ensure that validated cleaning and washing procedures are laid down and records maintain. Should review all the records.

2.9.          To ensure that the process of sterilization is performed as per the validated process. Record and rectify any deviations.

2.10.       To ensure that the process of detoxification of the toxin is performed as per the laid down procedure and the crude toxoid is passed to next step only after meeting the laid down specifications.

2.11.       To ensure that process of bulk manufacturing is controlled. Recoveries and yields at the critical stages meet the laid down specification.

2.12.       To ensure that the process of formulation is performed under strict aseptic conditions.

2.13.       To ensure that all the stored products, intermediates, equipments, instruments, utility lines etc. are labelled for better identification and to avoid mix-ups.

2.14.       To ensure that released intermediates, bulk purified tetanus toxoid and formulated bulk are properly labelled and stored under controlled conditions and released for next step after QA/QC approval.

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

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

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

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

2.19.       To monitor the performance of production team.

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

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

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

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

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

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

2.26.       Assign job responsibilities to production staff.

2.27.       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 purified bulk and formulated bulk to the approved storage area 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)