OBJECTIVE:

• To define a uniform, controlled procedure for handling any change in personnel, including change of role, resignation, or interdepartmental transfer.
•  To ensure continuity of responsibilities, proper documentation, and compliance with GMP and company policies.
•  To prevent loss of information, unauthorized access, or interruption in GMP activities during personnel changes.

 SCOPE:

• This SOP applies to all employees of Caisa Pharma, including permanent, contractual, trainees, and temporary personnel.
• This SOP covers promotions, demotions, job role changes, resignations, and transfers between departments.

RESPONSIBILITIES:

Human Resource Department (HR):

• Responsible for managing all personnel changes as per this SOP.
• To ensure handover, documentation, and access control changes are completed.

 Respective Department:

• Department Heads shall support the handover process and validate the completeness of activities.

 Information Technology (IT):

• IT shall update system access upon HR instruction.

 Quality Assurance (QA) Dept:

• QA shall ensure GMP responsibilities are transferred properly for personnel working in GMP areas.

 DEFINATIONS:

• Role Change: Any change in designation, responsibilities, or reporting structure.
•  Resignation: Voluntary separation from employment initiated by the employee.
•  Transfer: Movement of an employee from one department or location to another within the company.
•  Handover: Formal transfer of responsibilities, documents, and in-process work.

PROCEDURE:

Personnel Role Change (Promotion / Demotion / Responsibility Modification)

• Department Head shall raise a request for a role change with justification through email or discussion with Management.
• HR shall review qualification, experience, performance, and competency for the new role.
• HR shall prepare a revised Job Description (JD) and obtain approvals.
• Employee shall acknowledge and sign the new JD.
• HR shall update personnel records, organization chart, and HR master list.
• IT shall update system access as per the new role.

Personnel Transfer (Inter-Departmental / Intra-Departmental)

• Department Head shall request a transfer with justification and expected date through email or discussing with Management.
•  HR shall verify resource availability in receiving department.
•  HR shall coordinate discussion with both departments.
•  Employee shall complete pending work, ongoing documentation, and material handover.
•  Department Head shall certify that handover is complete.
•  HR shall issue internal transfer approval.
•  HR shall update JD if required.
•  IT shall modify access rights and assign new access where required.

Personnel Resignation / Separation:

• Employee shall submit a resignation letter or email to Department Head and HR.
•  Department Head or HR shall acknowledge resignation and inform concerned Department Head.
•  Employee shall serve notice period as per company policy unless waived.
•  A complete handover shall be performed, including:
• • Ongoing tasks
  • Documents and SOPs
  • Keys, and ID cards
  • Data, laptops, storage devices
  • GMP documentation (if applicable)
•  Department Head shall certify handover completion.
•  HR shall arrange exit interview and clearances with all concerned departments.
•  IT shall deactivate system access, email, and software rights.
•  HR shall close personnel file and record separation in HR system.

• QA shall ensure no pending GMP responsibilities remain open (e.g., deviations, CAPA, training gaps).

Handover Requirements:

• Handover must be done before the effective date of resignation, transfer, or role change.
•  All handover notes must be clear, signed, and acknowledged by both giving and receiving personnel.
• For GMP areas, the handover must include batch records, logs, controlled documents, open activities, and operational status.
• HR shall verify completion before approving final change.

System Access and Security Control:

• IT/Admin shall modify access rights only upon written instruction from HR.
•  Upon resignation, all access shall be revoked on the last working day.
•  For transfers, previous access shall be removed and new access granted based on job role.
•  QA shall review access rights for GMP-relevant systems (LIMS, ERP, documentation systems).

Document and Record Update Requirements:

HR shall update:

• Employee master data
• Reporting structure
• Organization chart
• JD file
• Training matrix

 QA shall update:

• Training files
• GMP competency documentation
• Authorized signature list
• Departmental responsibility charts

Notification and Communication:

• HR shall communicate personnel changes to:
  • • Department Heads
    • IT
    • QA
    • Security
    • Finance (for final settlement or revised salary)
•  HR shall update attendance and payroll systems when needed.

Training:

• All employees shall be trained on this SOP.
•  Newly appointed or transferred personnel shall receive additional training for new responsibilities as applicable.

REFERENCES:

NA

RECORDS:

 REVISION HISTORY.