OBJECTIVE:

• To establish a systematic procedure for preparing, reviewing, approving, issuing, and maintaining Job Descriptions (JDs) defining roles, responsibilities, and authority of each employee as per WHO GMP requirements.

SCOPE:

• This SOP applies to all employees across all departments (Production, Quality Assurance (QA), Quality Control (QC), Warehouse, Engineering, Human Resource (HR), Environment, Health and Safety (EHS), etc.) of the organization.

RESPONSIBILITIES:

HR Department:

• Prepare, issue, and maintain Job Descriptions for all positions.
• Ensure each employee has a signed and updated JD.
• Maintain JD master list and revision history.

Department Head:

• Define department-specific duties, roles, and reporting structure.
• Review and update JDs periodically or whenever job responsibilities change.

Employee:

• Understand and perform duties as per the JD.
• Sign and acknowledge receipt of their JD.

 DEFINATIONS:

• Job Description (JD): A written statement outlining duties, responsibilities, required qualifications, and reporting hierarchy for a specific position.
•  Authority: Level of decision-making power associated with a position.

 PROCEDURE:

Preparation:

• HR, in consultation with the Department Head, shall prepare a draft JD for each position using the Job Description Template

• The JD shall include at minimum:
  • Job title
  • Department and reporting line
  • Key duties and responsibilities
  • Key performance indicators (KPIs)
  • Signature and approval fields

 Review and Approval:

• Draft JD shall be reviewed by the QA Department for GMP and documentation alignment.
•  Final approval shall be given by the Managing Director.
•  Once approved, HR shall assign a control number (e.g., JD/QA/001) and file it in the JD master register.

 Issue and Acknowledgement:

• HR shall issue the approved JD to the employee at the time of joining or role change.
• The employee shall sign and acknowledge receipt of the JD.
• The signed copy shall be filed in the employee’s personal file.

Revision of Job Description:

• Revision shall be required if:
  • • Reporting structure changes.
    • Job duties or processes are modified.
    • Organization undergoes restructuring.
    • Department Head shall propose the change to HR.
• HR shall update the JD, assign a new revision number, and obtain necessary approvals.
• Obsolete JDs shall be stamped as “Superseded” and archived for at least 5 years.

REFERENCES:

• WHO TRS 986, Annex 2 — Good Manufacturing Practices: Personnel and Training
• ISO 9001:2015 — Clause 7.2 Competence

 RECORDS:

 REVISION HISTORY.