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Compliance Analyst

Job Posted at: 2020-02-12 09:26:00

Deadline

2020-03-11 09:48:00

Full Time

Description

Job Scope

  • 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 perform routine spot check at production shop floor to ensure good housekeeping activity in ancillary areas.
  • To assist in the circulation and closure of critical QMS documents & service requests.
  • To control the training file by actively updating training attendance, assessments and evaluations following training activity as per training plan.
  • 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.

Job Requirements

Minimum Working Experience

1 Year

Minimum Education

Diploma

Field of Study

Engineering (Others)

  • The Person:

  • Possess a recognized Bachelor Degree / Diploma preferably in Science / Engineering field.

  • Minimum 1 to 3 years of experience in pharmaceuticals industry.

Technical Competencies

  • 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

Behavioral Competencies

  • Good interpersonal and leadership skills, good planning and organizing / management skills, good communication and analytical skills, good efforts and initiatives, good attitude and discipline, integrity, independent, self-confidence, conceptual and analytical ability, achievement oriented & able to work under stress.

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