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JOB DESK

PAGE 1 FROM 5

Job Desk No. :

QC SUPERVISOR Effective Date :


PT. BIOTIS PHARMACEUTICALS
INDONESIA Review Date :

DEPARTMENT: SECTION: Supersedes : New

QUALITY CONTROL Date :

DISUSUN OLEH (Written By) : DIPERIKSA OLEH (Checked By) : DISETUJUI OLEH (Approved By) :

Sussi W. K Ita R Ita R


Quality Manager HRD Staff HRD Staff

IDENTIFICATION OF POSITION
Position Name: Supervisor
Report to : Quality Manager
Supervise : Microbiology and Chemical Lab Analyst

JOB SUMMARY
Ensuring that all of the functions of quality control system is implemented at PT. Biotis
Pharmaceuticals Indonesia (BPI). Responsible for the laboratory testings and the quality of
output with goal to support the quality management system. Organize all of the work plans
in quality control department. Support all the departments in line with production and
quality system. Conducts the jobs based on Good Manufacturing Practice and Good
Laboratory Practice requirements.

DESCRIPTION OF DUTIES AND RESPONSIBILITIES


Prepare documents regarding quality control methods and standards.
Supervise and monitoring all of quality control activities regarding media and equipments
preparation, laboratory testings, cleaning, and maintenance.
Ensure all testing and observation process appropriate with the established procedures.
Ensure all quality control activities appropriate with the quality management system.
Ensure all quality control activities support the production lines.
Responsible to establish inspection protocols, define sampling procedures, and determine
equipments and mechanism to be used in testing process.
Responsible to approve specification, sampling methods, testing methods, and other quality
control procedures.
Responsible the work, such as the implementation of calibration, qualification, and
validation as well as the implementation of employee training both job skills and general

Job Desk Code xxxx Dated xx/yy/zzzz Confidential


JOB DESK
PAGE 2 FROM 4

Job Desk No. :

QC SUPERVISOR Effective Date :


PT. BIOTIS PHARMACEUTICALS
INDONESIA Review Date :

DEPARTMENT: SECTION: Supersedes : New

QUALITY MANAGEMENT QUALITY CONTROL Date :

WRITTEN BY : CHECKED BY : APPROVED BY :

Sussi W. K …………Name………….. …………Name…………..


Quality Manager Position Position

(CPOB) and then documenting it.


Responsible for collecting and saving data and analysis regarding all results in quality control
laboratory.
Suggest improvements for better and effective laboratory work mechanism.
Suggest training requirement and planning for the improvement of personnel’s capabilities.
Overseeing the administrative implementation of the QC Department's activities, all records
ranging from tool usage notes, room records, reagent usage records, and media for product
testing or retesting activities, as well as drug raw materials.
Communicate and work together with all departments with the goal of optimum product
quality.
Develop and document various processes and prepare final reports.

JOB REQUIREMENTS
TERMS

CRITERIA
Sex
Male or Female
Age
25 – 30 years
Formal Education
Min. Graduated from Pharmacy/Apothecary
Work Experience
At least 2 years in laboratory working experience.
Other Requirements
Having knowledges in Good Laboratory Practice and Good Manufacturing Practice.

Job Desk Code xxxx Dated xx/yy/zzzz Confidential


JOB DESK
PAGE 3 FROM 4

Job Desk No. :

QC SUPERVISOR Effective Date :


PT. BIOTIS PHARMACEUTICALS
INDONESIA Review Date :

DEPARTMENT: SECTION: Supersedes : New

QUALITY MANAGEMENT QUALITY CONTROL Date :

WRITTEN BY : CHECKED BY : APPROVED BY :

Sussi W. K …………Name………….. …………Name…………..


Quality Manager Position Position

Having capability to prepare and conduct analysis methods.


Having good leadership and communication manner.
Team work oriented.
Good analyzing and interpretation skill.

AUTHORITIES
To conduct all the work plans in quality control department.
To establish inspection protocols, define sampling procedures, and determine equipments
and mechanism to be used in testing process
To supervise all of the laboratory quality testing process.
To analyze and interpretate all of laboratory testing results.
To have suggestions regarding improvement of quality control department.

DELEGATION
Analyst

HISTORY
Revision Effective date Reason of Change
New

DISTRIBUTION
QMD Manager
HRD Manager

Job Desk Code xxxx Dated xx/yy/zzzz Confidential


JOB DESK
PAGE 4 FROM 4

Job Desk No. :

QC SUPERVISOR Effective Date :


PT. BIOTIS PHARMACEUTICALS
INDONESIA Review Date :

DEPARTMENT: SECTION: Supersedes : New

QUALITY MANAGEMENT QUALITY CONTROL Date :

WRITTEN BY : CHECKED BY : APPROVED BY :

Sussi W. K …………Name………….. …………Name…………..


Quality Manager Position Position

_____________________End of the Document__________________________

Job Desk Code xxxx Dated xx/yy/zzzz Confidential

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