SOP for Job Description in Quality Control Department

1. PURPOSE:

This procedure ensure that all personnel have a clear understanding of their job responsibilities for work affecting quality, their interactions with other people, and the responsibilities of those with whom they work.

2.0  SCOPE:

       This procedure applies to all personnel in Quality Control (QC) department and covers the preparation of the organization chart and the assignment of responsibilities of QC staff.

•  RESPONSIBILITY:

All staff in Quality Control Department.

• ACCOUNTABILITY:

Manager – Quality Control.

• PROCEDURE:
  • Job Description:
    • The job description will define the day to day responsibilities of personnel in all the functional areas of the Organization.
    • Job descriptions for individual staff will be available. Every staff member will be given a copy of his/her Job Description. He /She will read and sign it, as acknowledgement of having understood and accepted the contents.
    • The Departmental Head will be responsible for the preparation and approval of Job Description.
  • ORGANIZATION CHART:
    • The organization chart shows the interrelations of staff.
    • The Quality Control Astt. Manager will prepare the Organization Chart and will be approved by the Manager QC.
    • Change in designation will be indicated only in the Organization Chart. Revised designation will be used in the document at the time of revision of amendment. All other documents should be read with the new designation in the place of the earlier designation.
    • RESPONIBILITIES FOR IMPLEMENTATION OF QUALITY MANAGEMENT SYSTEM (QMS).
      • The Manager – QC will be responsible for complete testing and approval or rejection of Raw material, packing material and finished products.
      • He/she will be responsible for preparing and checking of the operating level documents like Standard Operating Procedure (SOP), Certificate of Analysis (COA), Specification required for the products to be manufactured by the company as well as artwork developed for packing material.
      • He/she will identify problems which result in nonconformance of product and will be responsible for installing corrective actions to overcome these problems.
      • He/she will also be responsible for investigation of product complaints/out of specification (OOS) results and suggesting corrective measures.
      • He/she will also control the reprocessing of nonconforming product in consultation with the head of Quality Assurance.
      • He/she will also identify the needs for training and development of human resources and organize for training of personnel.
      • If required, He/she will organize the lab renovation and installation of new testing equipment.
    • Astt. Manager: (Reporting to Manager – QC/Plant Head):
      • Manage the shift.
      • Follow the planning for daily and committed achievement.
      • Making training schedule for QC staff.
      • Follow the special task which is given by Manager.
      • Complete reporting to Manager. 
    • Sr. Executive/Executive: (Reporting to Manager – QC/Astt. Manager QC)
      • Reporting to Manager /Astt. Manager about daily activity.
      • Execute the problem concerned to daily work.
      • Comply the cGMP, GLP norms and current SOP.
      • Motivation activity for their colleague and sub-ordinates.
      • Coordinate with related external department.
      • Preparation of SOP & STP.

• Sr. Officer: (Reporting to Sr. Executive/ Executive)
  • Responsible to maintain the cGMP, GLP norms and procedure in assigned area.
  • Completion of any other assigned work related to QC.
  • Process validation analysis and reporting.
  • Outside samples preparation and monitoring.
  • To impart formal online training to Jr. staff regarding SOP, STP and other QC activity.
  • To prepare online Certificate of Analysis, Test Data Sheet and to check log books.
  • Coordination with Executive for preparation of SOP and STP.

• Officer/ Jr. Officer: (Reporting to Sr. Executive / Executive)
  • To analyze the allocated sample with reporting online by filling the TDS and log books.
  • To give feedback immediately in case of any Out of Specification (OOS).
  • To complete any other assigned task.

• Trainee: (Reporting to Sr. Executive / Executive) 
  • Analysis of allocated sample and its online reporting.
  • Other jobs allocated by the senior staff.
  • DELIGATION AND RESPONIBILITIES:
    • In the absence of Head of Quality Control Department the Astt. Manager will take the charge and responsibilities of the Head of Department.
•   DISTRIBUTION:

          Master Copy         : QA Department

         Controlled Copy               :  Department

          Display Copy        : QC Department

7.0    ATTACHMENTS:

Sr. No.	Title	Annexure No.
01.	NA	NA

 8.0   REFERENCES:

    In-House.

9.0   ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
No.	Number
Ltd.	Limited
QA	Quality Assurance
QC	Quality Control
IT	Information Technology
ID	Identity
HPLC	High performance liquid chromatography
FTIR	Fourier Transform Infrared Spectrophotometer.
UV	Ultra Violet Visible Spectrophotometer
GC	Gas Chromatography

10.0  REVISION HISTORY OF CHANGE:

Sr. No.	Date	Revision Details	Revision No.
01	18.01.2020	NEW SOP	00