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Compliance Analyst

Job Posted at: 2019-10-24 17:55:00

Deadline

2019-11-23 17:55:00

Expected Salary

MYR 2400.00

Contract

Description

Job Scope

The Job:

  • To coordinate and control all data input efforts, including data entry, integrity and standardization of formats across Production department.
  • To perform trend analysis on all critical quality attributes (CQAs) found in Production dossiers.
  • To review and check the recording, filing and registering of information in Production’s dossiers.
  • To evaluate and compile the frequency of non-conformity & excursions in shop floor, and proposes mitigation plan to Production management team.
  • To assist in the administrative control of instruments in Production; including the environmental monitoring devices, weighing balances, calibration devices and IPQC testers.
  • To assist in the development of the training matrix essential for TNA, as well as the modules for GMP training.
  • To assist in project execution in the Production shop floor pertaining to GMP compliance enhancement.

The Person:

  • Possess a recognized Diploma preferably in Science / Mathematicsfield.
  • Minimum 1 to 3 years of experience in pharmaceuticals industry.
  • Good understanding on Production processes & Quality systems such as BMR & Deviations.
  • Good communication, management and report writing skills.
  • Good understanding and ability to interpret regulatory guidelines (PIC’s/TGA/FDA/EMA)
  • Have participated in any internal or external pharmaceutical GMP audit experience

Job Requirements

Minimum Education

Bachelor's Degree

The Person:

  • Possess a recognized Diploma preferably in Science / Mathematicsfield.
  • Minimum 1 to 3 years of experience in pharmaceuticals industry.
  • Good understanding on Production processes & Quality systems such as BMR & Deviations.
  • Good communication, management and report writing skills.
  • Good understanding and ability to interpret regulatory guidelines (PIC’s/TGA/FDA/EMA)
  • Have participated in any internal or external pharmaceutical GMP audit experience

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