STANDARD OPERATING PROCEDURE
TITLE: JOB DESCRIPTION
DEPARTMENT: QUALITY
SOP No. : QA-011-01 PAGE No. : 1 of 3
ASSURANCE
DISTRIBUTED TO: ALL EFFECTIVE DATE :
SUPERSEDES: QA-011-00
DEPARTMENTS NEXT REVIEW DATE:
1.0 OBJECTIVE
1.1 To lay down a procedure for defining job responsibilities of employees working in
all the departments with respect to their assigned duties at work.
2.0 SCOPE
2.1. This SOP is applicable for all employees working at
3.0 RESPONSIBILITY
3.1. QA Officer- Quality Assurance Department.
3.2. Operations & Production Manager – Production Department
4.0 ACCOUNTABILITY
4.1. Head QA - Quality Assurance Department.
4.2. Operation & Production Manager – Production Department
5.0 PROCEDURE
5.1. To maintain a satisfactory system of QA and manufacturing of drug product, as per
cGMP When an employee joins an organization and handed over to respective
department, after completion of induction, departmental as well as work related job
responsibility shall be issued to an employee.
5.2. Employee needs to complete the training as per the assigned Job Responsibilities.
Employee has to fill all the training records and Annexures as per the SOP QA-010.
5.3. Employee has to undergone the Medical check up procedure as per the SOP AD-004.
This is applicable for all new employees joined at .Once the training as per role
curriculum is completed employee will be handed to the department head for briefing the
job responsibility to the employee.
PREPARED BY CHECKED BY APPROVED BY
SIGN AND DATE
NAME &
DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: JOB DESCRIPTION
DEPARTMENT: QUALITY
SOP No. : QA-011-01 PAGE No. : 2 of 3
ASSURANCE
DISTRIBUTED TO: ALL EFFECTIVE DATE :
SUPERSEDES: QA-011-00
DEPARTMENTS NEXT REVIEW DATE:
5.4. Employee will read the job responsibility details carefully and shall accept the same and
sign on the annexure-I provided. Roles and Responsibility of each employee shall be
prepared as per the department or designee in an annexure –I.Job responsibility can be
updated or revised depending on the new changes of the procedure or new equipment
added which are handled by the same personnel..
5.5. Before revision of job responsibility annexure, it shall be ensure that employee should be
completed with the training as per the new job role that is assigned. Once the training is
completed, job responsibility annexure for particular personnel shall be revised with
required updates.
5.6. Previous version of Job Responsibility annexure for the personnel will be obsolete.
5.7. Job responsibility annexure shall consist of information such as employee name, date of
joining, designation or title, date of joining, job responsibility effective date, immediate
reporting to, department head, and list of responsibilities to be performed by employee.
5.8. Approved Job responsibilities of all the employee working at shall be maintained by
QA department in respective file.
5.9. Respective department Heads need to ensure that updated job responsibility annexures of
all employees need to be submitted to QA after approval.
6.0. ABBREVIATIONS:
6.1 QA – Quality Assurance
6.1 SOP – Standard operating procedure
6.1 cGMP – Good Manufacturing Practices
7.0. REFERENCES
7.1 Nil.
8.0. ANNEXURES
PREPARED BY CHECKED BY APPROVED BY
SIGN AND DATE
NAME &
DEPARTMENT
STANDARD OPERATING PROCEDURE
TITLE: JOB DESCRIPTION
DEPARTMENT: QUALITY
SOP No. : QA-011-01 PAGE No. : 3 of 3
ASSURANCE
DISTRIBUTED TO: ALL EFFECTIVE DATE :
SUPERSEDES: QA-011-00
DEPARTMENTS NEXT REVIEW DATE:
8.1. Annexure-I : Job Responsibilities Form
8.2. Annexure-II: Department Organogram
9.0. SUMMARY OF CHANGES
Change control No. Effective from Date Reason for revision
NA NA New SOP
END OF DOCUMENT
PREPARED BY CHECKED BY APPROVED BY
SIGN AND DATE
NAME &
DEPARTMENT
