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Compliance Executive

Job Posted at: 2019-04-29 17:19:00

Location

Selangor

Deadline

2019-05-29 14:19:00

Full Time

Description

Job Scope

  • To provide delegation and support for all initiatives concerning compliance improvement activities, aimed to enhance the cGMP and GDP practices in Manufacturing area.
  • To actively liaise with relevant PICs in Manufacturing and external stakeholders to devise realistic action plan aimed to close the gaps of non-compliances in Material & Finished Goods Warehouse; and the subsequent tracking of the execution
  • To lead and execute the internal walkabout and compliances audits at the Manufacturing site, and to discuss with individual PICs on the findings for closure.
  • To develop, maintain and track the execution of all training needs analysis and training plans for Manufacturing staffs.
  • To review, monitor and continually update the risk and gap assessment of the routine operation in Manufacturing area; and to follow up with the treatment execution for closure.
  • To support and coordinate all preparation work in documentation and housekeeping of the Manufacturing team in response to planned and unplanned major external audits
  • To undertake pertinent compliance improvement project, in line with company’s business and quality direction.

The Person:

  • Possess a recognized Bachelor Degree preferably in Science / Engineering field.
  • Minimum 2 to 3 years of experience in pharmaceuticals industry.
  • Good understanding on production processes such as manufacturing of oral solid dosage form, liquid, creams and softgels.
  • Good communication, management and report writing skills.
  • Good understanding and ability to interpret regulatory guidelines (PIC’s/TGA/FDA/EMA)
  • Basic understanding of Critical facility such as HVAC, water system, Sterilization system, equipment qualification and compressed air.
  • Good interpersonal and leadership skills
  • Good planning and organizing / management skills,
  • Good communication and analytical skills,

Job Requirements

Minimum Working Experience

2 Years

Minimum Education

Professional Degree

Minimum Grade

Second Class Upper

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