Job Responsibilities of QA Personnel

1.0 OBJECTIVE 

To lay down a procedure for job description and responsibilities of personnel working in Quality Assurance Department. 

2.0 SCOPE

This procedure is applicable to Quality Assurance department present in the XXX Company Limited.

3.0 RESPONSIBILITY

3.1 Head-Quality Assurance

4.0 PROCEDURE

4.1 Position: Head-Quality Assurance

4.1.1 Ensure compliance of national and international regulatory cGMP requirements.

4.1.2 Approve and verify the implementation of systems defined in the SOP, Validation and Qualification of the Equipment.

4.1.3 Ensures compliance of change control procedures

4.1.4 Investigate complaints, deviations and non conformances

4.1.5 Investigate the Product recall

4.1.6 Verify the changes made to the system through change control procedure.

4.1.7 Ensures the Qualification of vendors for key raw materials.

4.1.8 Ensures Master validation policy is in place and validation of Analytical methods, Cleaning methods and Process.

4.1.9 Ensures that the systems are maintained by periodic internal auditing procedure.

4.1.10 Ensures the preparation of Annual product reviews and make suggestion for process improvement.

4.1.11 Ensures Documentation control system is in place.

4.1.12 Ensures proper storage and retrieval system are in place.

4.1.13 Responsible for conducting training records for newly joined Employees.  

4.2 Position: Sr. Executive-Quality Assurance

4.2.1 Review the Standard operating Procedures generated in the Quality Assurance department and verify the SOPs generated by the other departments.

4.2.2 Issuance, retrieval and  Review the Batch manufacturing and Packing Records

4.2.3 Distribution and retrieval of the SOPs to and from the Author Departments. 

4.2.4 Preparation of Protocols and reports for Process validations, cleaning validation.

4.2.5 Protocols and reports are compiled for qualification documents.

4.3 Position: Executive- Quality Assurance ( Documentation)

4.3.1 Preparation of Quality Assurance standard operating procedures

4.3.2 Artworks preparation and distribution to the respective departments.

4.3.3 Issuance of formats for the concerned departments.

4.3.4 Updating of vendor list regularly

4.3.5 Raw and packing materials sampling

4.4 Position: Executive-Quality Assurance (In-process)

4.4.1 Online inspection of Every production operation

4.4.2 Responsible for the line clearance for Manufacturing Batch.

4.4.3 Inspection of dispensing booth prior to the raw material dispensing and check the raw material weighing procedures.

4.4.4 Ensure that the cleaning of equipment shall be done at appropriate time.

4.4.5 Preparation of QA SOPs.

4.4.6 In-process checks shall be performed.

4.4.7 Ensure that the production operations are done as per the Quality management system laid by the quality Assurance.

4.4.8 Finished product sampling and issue of control samples to QC.

5.0 ABBREVIATIONS

5.1 QA- Quality Assurance

5.2 SOP- Standard Operating Procedure

5.3 cGMP- Current Good Manufacturing Practice

6.0 ANNEXURE

6.1 Annexure-1: Job responsibilities of QA Staff