Job Responsibilities of Key Personnel

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Job Responsibilities of Key Personnel

1.0 Objective
To provide guidelines for roles and responsibilities of key personnel in the plant
2.0 Scope
This SOP applies to the key personnel working in abc company.
3.0 Responsibility
3.1 All Supervisor of HR & Administration
3.2 Manager/ Head Concern Area
3.3 Director to guide the roles and responsibilities of key personnel.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
HR : Human Resource
CC NO : Change Control Number
cGMP : Current Good Manufacturing Practice
HOD : Head of Department
5.0 Procedure
5.1 All the employees working in plant will be given the roles & responsibilities by

the Management by their name as per annexure-I.
5.2 The roles & responsibilities will be depending upon the nature of the work of

the candidate and related to his department.
5.3 Before ascertaining the roles & responsibilities the employees will be

briefed/trained with related their roles.
5.4 The employees should follow some of the key roles & responsibilities,

which were derived by the management.
1. Organization chart
2. Roles & responsibilities of G.M. Plant
3. Roles & responsibilities of Manager QA
4. Roles & responsibilities of Manager QC
5. Roles & responsibilities of Production Manager.
6. Roles & responsibilities of Maintenance Manager.
7. Roles & responsibilities of Manager Ware house.
8. Roles & responsibilities of HR Manager.
9. Roles & responsibilities of Accountant.
5.5 General Manager- Plant
Reporting to Managing Director
5.5.1 Productivity identifies areas of obstruction / breakdowns and take step to rectify

the equipments / process and quality thereby enhancing productivity.
5.5.2 Executing cost saving techniques & modification to achieve substantial reduction in cost.
5.5.3 Periodic performance evaluation of productivity and technical audit for loan license and P to P product
5.5.4 Vender development & inspection by providing technical guidance to deliver quality products.
5.5.5 Proficient in planning & executing in maintenance, calibration, troubleshooting of

Machines / equipment / process and quality thereby enhancing productivity.
5.5.6 Coordination with various government department / drug control department

to get the required statutory licenses.
5.5.7 Compliance of quality measures and various technical audits

such as ISO 9001, 14001, cGMP, WHO-GMP and international audits.
5.5.8 New drugs Mfg. License & additional product approval from Drug authority also DCGI approvals.
5.5.9 To design & executive the total productivity management “TPM” and Total Quality Management.
5.5.10 To design the quality management system and implementation the same per cGMP norms.
5.5.11 Review & approval of annual budget.
5.5.12 To co-ordinate between various departments including H.O.
5.5.13 Overall incharge of security of the plant.
5.5.14 To check & approve the bills and local purchase.
5.5.15 To ensure adherence of all statutory requirement, cGMP and implementing of all safety measures.
5.5.16 To effectively use the available resources for carrying out day to day production activities

which includes Proper planning, Proper utilization of manpower & Proper working of machineries and utilities.
5.5.17 To organize / impart training to all technical personnel and workmen on safety cGMP, adherence to SOP etc.
5.6 Quality Assurance Manager
Reporting to General Manager Plant
5.6.1 Efficiently managing and streamlining of Quality Assurance related activities and handling

all Quality related problems by appropriate and timely decisions.
5.6.2 To ensure that GMP and Good Laboratory Practices (GLP) are implemented properly.
5.6.3 To perform and responsible for all WHO related work.
5.6.4 To ensure that adequate controls on starting materials, intermediate products,

and bulk products & other inprocess controls.
5.6.5 Approval and controls of quality system documents such as vendor qualification, equipment

qualifications, Process Validation, stability and analytical method validations.
5.6.6 Preparation of periodic and annual product quality reviews of all products manufactured at site.
5.6.7 Preparation and submission of all documents required to regulatory department for

onward submission to regulatory authorities.
5.6.8 To ensure that the finished products is correctly processed and checked

in accordance with established procedures.
5.6.9 Review of batch manufacturing record, batch packaging record,

and testing record of all batches.
5.6.10 Responsible for approval of batch manufacturing records and released

of products for sale & distribution.
5.6.11 Review of records of calibration, preventive maintenance and product change over.
5.6.12 Responsible for the internal audit program as per the established procedures.
5.6.13 Handling of change control and deviations as per the established procedures.
5.6.14 Participation in the investigation during product failures and customer complaints.
5.6.15 Closure of all investigation within the stipulated time and periodic monitoring

of the effectiveness of the CAPA.
5.6.16 Issue Validation and Calibration protocols and reports; Export related documents,

Analysis and testing reports and approval of the same.
5.6.17 Review and approval of FDA related documents.
5.7 Quality Control Manager
Reporting to General Manager Plant.
5.7.1 Efficiently managing and streamlining of all Quality Control related activities and

handling all Quality related problems by appropriate and timely decisions.
5.7.2 Ensuring that the GLP implemented properly as per schedule L1.
5.7.3 Responsible for training of laboratory personnel and records of its.
5.7.4 To check the maintenance of the Quality Control Department, premises and equipment
5.7.5 Overall administrative functioning of Q.C. Dept.
5.7.6 To maintain laboratory documents & instruments of QC as per cGLP.
5.7.7 Ensures that, all analytical instruments are calibrated and serviced as scheduled.
5.7.8 Ensures proper sampling, correct testing / analysis and release of, Raw Materials,

Packing Materials, Potable, Purified Water, and Inprocess Samples & Finished Products & approved of it.
5.7.9 Review of analytical reports and related analytical data of QC department then approval of the same.
5.7.10 Calibration of related equipments / instruments and other measuring devices is done in

accordance with standard / written procedures & schedules and approval of it.
5.7.11 Checking of all QC related records logbook of QC instruments, solution preparation record,

calibration records etc on daily basis.
5.7.12 Preparation of standard testing procedure of Raw Materials, Bulk and Finished products.
5.7.13 Checking of daily sample status RM, PM, Bulk, FG and Micro samples and distribution to the samples.
5.7.14 Maintenance of reference standards and working standards and records of its.
5.7.15 Responsible for approval & release of raw material, packing material, bulk samples and finished

products chemically, instrumentation and microbiologically analysis.
5.7.16 To organize stability study program and confirm the assigned shelf life of products.
5.7.17 Updating of specifications as and when required and review and approve analytical results.

5.8 Production Manager
Reporting to General Manager Plant
5.8.1 Plan availability of raw materials and packaging materials for the current running month.
5.8.2 Proper manpower planning in coordination with Personnel Department and work allocation.
5.8.3 Identify training need of manpower employed in each department and coordinate with QA/HRD to train them.
5.8.4 Correct planning and execution of production plans on day to day basis to achieve set (monthly) targets.
5.8.5 Smooth coordination with other related departments – Raw Material Stores,

Maintenance, Finished Goods Store and QA.
5.8.6 To maintain & follow GMP Operation standards strictly.
5.8.7 To maintain cycle time and standard yields within limits.
5.8.8 Periodic training of Officers and workmen for various aspects of GMP, Machine Productivity and quantity.
5.8.9 Responsible for cleaning of manufacturing areas and also manufacturing equipments.
5.8.10 Tackle market complaints in coordination with Quality Assurance Department.
5.8.11 Resolving day to day labour problems, machine problem planning.
5.8.12 Maintain documented evidence of all work related matters and cGMP books.
5.8.13 Upkeep of the department / sections.
5.8.14 To review condition of machine, to plan preventive maintenance or to process new

M/C as per requirement of production.
5.8.15 To review daily production report & to guide the Department for achieve production targets.
5.8.16 To assist GM Works for giving response.
5.8.17 To indent requirement of inventory required for various Department.
5.8.18 To recruit the manpower (company) required for production plan.
5.8.19 To check the Batch Manufacturing Record.
5.8.20 Maintain Dignity and Discipline.
5.8.21 Before starting the Batch update the batch no and date of manufacturing.
5.9 Manager Engineering
Reporting to General Manager Plant
5.9.1 Responsible for Engineering dept., all Utilities and Engineering stores.
5.9.2 Facility planning of civil, electrical, instrumentation and mechanical works.
5.9.3 To review smooth function of Effluent treatment plant, its maintenance and to comply all legal requirements.
5.9.4 To prepare master preventive plan for various machines of all departments and utilities and approval of it.
5.9.5 Staff training and development
5.9.6 To ensure compliance to cGMP guidelines and SOPs within the Eng. Dept.
5.9.7 To ensure proper utilization of electricity, & water.
5.9.8 To procure spares & material required for machine of all dept. & approval of it.
5.9.9 To take round of production, Q.C., stores, BSR & Utility and check performance of smooth working of machine.
5.9.10 Maintenance of building, prepare plan for maintenance of building.
5.9.11 Co-ordination with production, RMS, FGS & GM Works.
5.9.12 To monitor inventory for a required stock level of spare parts of equipment to minimize the total breakdown time.
5.9.13 To prepare plan for renovation, upgradation of various dept. and execution of it.
5.9.14 To develop various vendors, suppliers for Engg. Material.
5.9.15 To prepare & approve annual maintenance contract for outside agencies and follow their work as per schedule.
5.9.16 Co-ordinate with contractors in the preparation of service contracts and GMP agreements
5.9.17 To organize validation of existing and new process, equipment & facilities
5.10 Manager – BSR and Stores
Reporting to General Manager Plant
5.10.1 Proper receipt of materials as per order specifications.
i. Raw Materials
ii. Packing Materials
iii. Engineering Items
iv. Miscellaneous Items
5.10.2 Proper labeling of received material for quick and easy identification / status.
5.10.3 Proper dispensing and issue of material as per laid down procedures and documentation thereof.
5.10.4 Maintenance of stock status and relevant documentation work.
5.10.5 Proper storage of materials as per storage conditions of the materials.
5.10.6 Overall functioning of the department is as per cGMP guidelines and documented evidence of the same is maintained.
5.10.7 Timely procurement of raw and packing materials in coordination with Purchase Department

(at Head Office,) as per the production plans.
5.10.8 Proper segregation and stacking of the received materials as per laid down procedures.
5.10.9 Ensure that sampling of Raw Materials and Packing Materials is done as per work Instructions.
5.10.10 Ensure proper upkeep of the department, including sanitization, checks on AC storage etc.
5.10.11 Co – ordinate with Manager Quality Assurance for maintenance of scrap yard.
5.10.12 Overprinting of cartons, rodent control, handling of rejected materials.
5.10.13 Preparation of local purchase indent.
5.10.14 Receipt of finished goods from each production section on day to day basis as per standard

procedures and maintain documents thereof.
5.10.15 Proper segregation and stacking of the received finished goods as per laid down

procedures till they are dispatched.
5.10.16 Market Release Order’ is obtained from the Quality Assurance Department

for the transferred finished goods before dispatch the products.

5.10.17 Released finished goods are dispatched to the market as per schedule

received from Distribution & Logistics Dept.
5.11 HR Manager
Reporting to General Manager Plant
5.11.1 Responsible for all the Recruitments & Appointments at the works.
5.11.2 To check housekeeping of factory premises and surrounding of factory premises.
5.11.3 Control of Movement of Vehicles, Man & Material.
5.11.4 Smooth functioning of security, housekeeping & canteen contractors.
5.11.5 To maintain attendance, leave record of Staff, workers, contract workmen and to prepare salary / wages.
5.11.6 Maintain discipline in plant, to take appropriate disciplinary action in consultation with Head Office.
5.11.7 Grievance handling time to time with consultation of General Manager Works.
5.11.8 Recruitment of Staff, Workers & Contract Workmen with co-ordination of different department.
5.11.9 Compliance & statutory matter covered under factory & payment wages & liaison work of

Provident fund, Employment exchange, Professional tax, police authorities, Factory inspector and Telephone exchange.
5.11.10 Provide medical services in case of accident and annual medical checkup.
5.11.11 To prepare, disaster management plan and to keep all requirement update.
5.11.12 Submission, renewal of factory license & contract labour license.
5.11.13 Preparation of contact agreement deeds with different contractors.
5.11.14 To initiate different activities for labour welfare.
5.11.15 Employees wage, Performance appraisal, Canteen, First-Aid and Welfare & Industrial Relations.
5.11.16 Observance of disciplined behavior and safety norms within the company.
5.11.17 Reviewing and appraising performance of personnel reporting to him and identifying their training needs.
5.11.18 Safety, Security and Protection from Fire & other hazards.
5.12 Accountant Manager
Reporting to General Manager Plant
5.12.1 Checking and Evaluation of bills (Raw material and Packing material).
5.12.2 Bank Re-conciliation.
5.12.3 Maintain and control of Cash.
5.12.4 Deposit of Sales Tax Return (Prepare all concerned documents).
5.12.5 Deposit of Excise Return.
5.12.6 Payment of E.S.I. and P.F.
5.12.7 Checking of Vehicle bill and payments as required.
5.12.8 Checking of Engg./QA-QC/ misc. bills and payments as required.
5.12.9 Checking of Contractor bill and payments as required.
5.12.10 Payment of day to day expenses as required after approval from GM/HOD.
5.12.11 Follow up for Purchase Orders of Raw material and Packing material.
5.12.12 Dispatch of all original bills/vouchers / related documents to H.O., Goa.
5.12.13 Payments of Local parties as required.
5.12.14 Entries in accounting software like purchase/journal/cash bills/vouchers.
5.12.15 Maintain of record of T.D.S.
5.12.16 Maintain and filling of Government documents like agreements.
5.12.17 Solve the queries of H.O. (accounts related).
5.12.18 Any other Accounts related work.
6.0 Forms and Records
6.1 Job Responsibilities – Annexure-1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Quality Assurance, Personnel and Administration, Production
8.0 History