Procedure For Job Responsibilities Of Individual Person 1

1.0 OBJECTIVE for Job Responsibilities

1.1 To lay down the Procedure for Job Responsibilities of Individual person.

2.0 SCOPE for Job Responsibilities

2.1 This SOP is applicable for defining Job Responsibilities of employees in all the departments.

3.0 RESPONSIBILITY for Job Responsibilities

3.1 Officer-QA

3.2 Manager-Concern Department

4.0 ACCOUNTABILITY for Job Responsibilities

4.1 Head- Quality Assurance

5.0 PROCEDURE for Job Responsibilities

5.1 Total operation is divided into various functions, called as departments. Following are the departments.

5.1.1 Warehouse
5.1.2 Production
5.1.3 Engineering & Utility
5.1.4 Quality Control
5.1.5 Quality Assurance
5.1.6Human Resources (HR)

5.2 Each department personnel shall be provided with defined responsibility to perform the task in individual department.
5.3 When employee joins an organization and handed over to respective department by HR after completion of induction, departmental as well as work related role curriculum shall be issued to an employee.
5.4 Once the training as per role curriculum is completed, now employee is ready to perform task as per dedication of job, department head shall issues job responsibility to the employee.
5.5 Employee will review the job responsibility details and shall accept the same.
5.6 Roles and Responsibility of each employee shall be prepared as per predefined Annexure: QA055-A01.
5.7 Job Responsibility can rotate as per requirement.
5.8 Before job rotation it shall be ensure that employee has completed the training as per new job role to be assigned.
5.9 Job Responsibility shall consist of information such as employee name, employee code, date of joining, designation; department head shall approve his job description.
5.10 An Organogram for each department shall be prepared by department head.
5.11 The duties of each key person or his deputy are defined but not limited.

5.12 Manager-HR.

5.12.1 Shall report to Managing Director.
5.12.2 To prepare procedure and conduct for personnel hygiene medical check-up on regular basis.
5.12.3 Employee Welfare.
5.12.4 To coordinate for training to all employees.
5.12.5 To manage pest control in plant premises.
5.12.6 The department head shall ensure that adequate number of personnel with necessary qualification and experience are provided to complete the departmental responsibility.
5.12.7 To be manage housekeeping in plant premises.
5.12.8 To manage dress code and its cleaning frequency.

5.13 Manager-Warehouse.

5.13.1 Manager-Warehouse shall be report to General Manager.
5.13.2 To monitor and execute the stores operations and report to General manager.
5.13.3 Shall control receipt and issue of raw materials and packing materials.
5.13.4 Shall ensure the daily activities are updated in respective records.
5.13.5 Shall prepare monthly stock statements of raw materials and packing materials.
5.13.6 Shall ensure Good manufacturing practice during receipt and issue of raw materials and packing materials.
5.13.7 Shall Preparation and review of the instruction for describing the receipt, identification, quarantine, storage and handling of raw materials/ Packing materials/ Finished product.
5.13.8 Environmental monitoring of the area as per predefined procedures.
5.13.9 Making sure that any deviation is reported and investigated properly.
5.13.10 Making sure that storage area is cleaned.
5.13.11 Inventory control.

5.14 Manager-Production.

5.14.1 Overall responsibility of manufacturing activities in the department and shall report to General Manager.
5.14.2 Responsible for implementing the cGMP in manufacturing area strictly.
5.14.3 Responsible for adherence to SOP, and ensure that same are implemented by all the staff members and employees in the department.
5.14.4 Preparing and reviewing the instructions for the production of products according to written procedures.
5.14.5 Producing products according to pre-approved specification.
5.14.6 Reviewing all production batch records and ensuring that are completed and signed.
5.14.7 Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and conclusions are recorded.
5.14.8 Making sure those productions facilities are clean and disinfected when appropriate.
5.14.9 Making sure that the necessary calibrations are performed and recorded in respective areas.
5.14.10 Making sure that the premises and equipment are maintained and recorded in respective areas.
5.14.11 Evaluation of proposed changes in product, process or equipment.
5.14.12 Making sure that new and when appropriate, modified facilities and equipment are qualified.

5.15 Manager-Quality Control

5.15.1 Release / Reject of raw material / Packing Material/Finished Product.
5.15.2 Making sure that critical deviations are investigated and resolved.
5.15.3 OOS Investigation & Out of trend investigation.
5.15.4 Gap Analysis.
5.15.5 Preparation and Standardization of volumetric solutions and reagents.
5.15.6 Inventory control of chemicals / Glassware’s / media etc.
5.15.7 Preparation and review of all SOP’s related to department, Specification and test procedures.
5.15.8 Initiation and review of any change related to the department.
5.15.9 Preparation and execution of validation protocol for method validation and Analyst validation.
5.15.10 Making sure that materials are appropriately tested and results are reported.
5.15.11 To conduct Stability Studies.
5.15.12 Calibration of instruments used in the Laboratories.
5.15.13 Handling of Reference standard and Working standard and qualification of working standard.

5.16 Manager-Quality Assurance

5.16.1 Overall responsibility related quality and directly reporting to MD.
5.16.2 Review of Manufacturing Processes: Ensures that manufacturing processes meet the required quality standards by reviewing the manufacturing procedures, batch records, and testing protocols.
5.16.3 Product Release: Products shall be released only after they have met the required specifications and are deemed safe and effective.

5.16.4 Collaborates with the Quality Control (QC) team to ensure that laboratory testing is conducted appropriately and meets the required specifications.
5.16.5 Audit: Conducts regular internal audits of the manufacturing facility to ensure that the facility meets the required quality standards. Also handles the external audit and its compliance.
5.16.6 Documentation: Responsible for ensuring that all necessary documentation is completed accurately, in a timely manner, and in compliance with regulatory requirements.
5.16.7 Deviation Management: Responsible for reviewing and approving deviation reports and ensuring that corrective and preventive actions (CAPA) are implemented.
5.16.8 Complaint Handling: Responsible for reviewing and investigating product complaints to ensure implementation of corrective and preventive actions (CAPA).
5.16.9 Product recall: Responsible for reviewing and investigating product which are called back due to some defects in the products and ensure implementation of root cause analysis (RCA) and corrective and preventive actions (CAPA).
5.16.10 Training: Responsible for training of manufacturing and laboratory personnel on quality-related procedures and regulations.
5.16.11 Laboratory incidents: Handling of out of specification (OOS) and out of trend (OOT) laboratory incidents and their closing.
5.16.12 To be review the method of analysis (MOA), standard testing procedure (STP) and other documents related to QC.
5.16.13 Non-conformity: Handling of non-conformity as per defined procedure.
5.16.14 SOPs(Standard operating procedure): Review & implementation of SOPs related to the concerned department.
5.16.15 BPR: Implementation & verification, in-process checks, online entries in BPR of product at manufacturing site.
5.16.16 GMP: Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.
5.16.17 GLP: Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal during the routine analysis and instrument operation ensure adherence to procedure.
5.16.18 Quality Risk Assessment: Preparation and review of Quality Risk Assessment in all area.
5.16.19 Product specifications: Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.
5.16.20 Standard for products: Identifies and sets appropriate quality standards and parameters for products.
5.16.21 New technologies: Evaluate new technologies and methods to make recommendations regarding their use.
5.16.22 Other documentation: To prepare the Validation Master Plan, Site Master File, Annual Product Quality Review, Plant Layout and other documents related to QA.

5.17 Manager – Engineering & Utility.

5.17.1 Manager-Eng. & Utility shall reported duty to MD/QA.
5.17.2 To co-ordinate project/renovation work in the factory.
5.17.3 To plan all preventive maintenance and break down maintenance activities.
5.17.4 Responsible for procuring the machinery spare parts for equipment’s.
5.17.5 Preparation and review of the instruction for describing the procedure for preventive maintenance, breakdown maintenance.
5.17.6 Evaluating any change in equipment, machinery.
5.17.7 Operation of all Utilities like Water, HVAC, Compressed Air etc.
5.17.8 Execution of Installation and Operational Qualification of equipment as per approved protocol in relevant documents and record.

6.0 ABBREVIATION for Job Responsibilities

6.1 SOP : Standard Operating Procedure.
6.2 QA : Quality Assurance.
6.3 IPQA : In-process Quality Assurance
6.4 QC : Quality Control
6.5 PPIC : Production planning and inventory control