ROLE, RESPONSIBILITY & JOB DESCRIPTION OF PERSONNE

SUBJECT :                                             ROLE, RESPONSIBILITY & JOB DESCRIPTION OF PERSONNE

DEPARTMENT           : QA SOP NO.                      Page No                       : 1 of  3 Effective Date             : Next Review                : SOP VERSION            :

             

1.0  OBJECTIVE:

To provide the role, responsibility & job description of the staff working.

2.0        SCOPE:  

To assign job description and respective work to all staff in all departments (Workman and operators are not covered).

                                           

3.0       PROCEDURE: 

3.1.      Q.A. department plays an important role in day to day work of the plant with respect to approval or rejection of Raw Material, Packing Materials, in process bulk & finished goods. It also looks into the details of system implementation and cGMP practices.

3.2.      They will attend to the regular Dispensing of RM’s, sampling and analysis of RM, IP, FP and PMs & records will be maintained. Role, responsibility & job description of each personnel is maintained as in Annexure -1. 

3.3.      Executive QA will be responsible for issuing BMR& BPR documents, giving line clearance and checking of online documents during manufacturing.

           

3.4       Executive QA will be responsible for Calibration of the equipments, preparation of specifications and SOP’s.

3.5.      General Manager QA will be the overall incharge & responsible for the various activities of the department. He will guide to the Q.A, Q.C staff in various aspects of Quality Assurance functions i.e. GMP, GLP, Testing procedures, Sampling procedures and Recording of results G.M (Q.A) will guide the Q.A. staff in understanding and following various standard procedures of Quality Assurance. He will also guide Executives and chemists of the Department in day to day working.

3.6       LAB ASSISTANTS: To assist the Q.A. Staff in day to day work and help them in maintaining the department in a clean and orderly fashion.

PREPARED BY                                 REVIEWED BY                                     APPROVED BY EXECUTIVE (Q.A)                      PRODUCTION MANAGER                          G.M (Q.A)

                                                                                        

                                                                                                           

                                                                                                

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3.7       The Production Manager will look into the planning of production, deployment of production, executives and chemists under him to various departments.

3.8       The production executives will look into the manufacturing & packing of products, maintaining the manufacturing records, manufacturing areas, equipments, log books and other activities in manufacturing areas.

3.9       The stores executives will look into the day to day administration of the stores and maintain all related documents, update SAP entries, dispensing of RM’s & PM’s for manufacturing. They keep the stores in an orderly fashion.

3.10     The maintenance manager will look into the day to day planning & execution of related jobs.

He is also responsible for identifying and purchasing of new machinery. He will depute maintenance staff to various departments for smooth running of the plant.

4.0       FREQUENCY: As and when required.

5.0       RESPONSIBILITY:   G.M (Q.A).

6.0       REVIEW GUIDE:  GMP and cGMP.

7.0       ANNEXURE: 1. Job Description of Person.

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	√
Warehouse	x	√
General	x	√
Maintenance	x	√

PREPARED BY                                 REVIEWED BY                                      APPROVED BY EXECUTIVE (Q.A)                      PRODUCTION MANAGER                          G.M (Q.A)