SOP FOR JOB RESPONSIBILITIES

1. Introduction:

The SOP for Job Responsibilities is established to clearly define the duties, authority, and accountability of personnel working in different departments of a pharmaceutical organization. Its main purpose is to ensure that every responsible person understands what work is assigned to them, how it should be performed, and who is accountable for completing and supervising the activity. The SOP applies to responsible personnel across the organization, while department heads are responsible for its execution and the Head of QA/QC ensures its effective implementation. Clear job responsibilities are an important part of a pharmaceutical quality system because manufacturing and quality-related activities must be carried out in a controlled and organized manner according to cGMP requirements. The SOP therefore distributes responsibilities among key functions such as Warehouse, Production, Engineering & Utility, Quality Control, Quality Assurance, and Personnel & Administration. These responsibilities cover important activities including material receipt and storage, production operations, equipment maintenance and calibration, qualification and validation, laboratory testing, batch-record review, deviation investigation, change control, self-inspection, vendor evaluation, product quality review, market complaints, recalls, employee training, hygiene, and housekeeping. The SOP also provides a Job Responsibility Format for documenting an employee’s name, qualification, experience, designation, department, date of joining, assigned responsibilities, acceptance, alternate responsibility during absence, and authorization. This helps establish documented accountability and continuity of work. Overall, this SOP helps prevent confusion, duplication of work, missed activities, and unclear accountability while supporting consistent pharmaceutical operations and effective implementation of the quality system.