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QMS Director with FDA Regulations Experience || Pharmaceutical Manufacturing || Pasir Gudang

RM 20,000 - RM 35,000 / month

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Job Description:

  • Review and approve quality-related documents, and conduct product quality reviews.
  • Release or reject APIs and intermediates, including raw materials, packaging, and labeling materials.
  • Ensure investigation and resolution of critical deviations and quality complaints.
  • Approve all specifications, master production instructions, and procedures impacting product quality, including those for contract manufacturers.
  • Oversee internal audits, and ensure maintenance and calibration of critical equipment.
  • Ensure proper material testing and reporting, including stability data to support retest/expiry dates and storage conditions.

Job Requirement:

  • Bachelor's degree or higher in Chemistry, Biology, Pharmacy, or related field.
  • Minimum 7 years in the pharmaceutical industry, with at least 5 years in a QA Manager role.
  • In-depth knowledge of ICH Q7 guidelines, FDA, and EDQM audit processes.
  • Proven experience leading quality organizations in a global matrix environment. Ability to make quality decisions in challenging situations.
  • Proficiency in written and verbal English. Mandarin is a plus.
  • Strong leadership, interpersonal, and communication skills.

Salary Range:

  • Open for discussion, please don't worry about budget

Job Types: Full-time, Permanent

Pay: RM20,000.00 - RM35,000.00 per month

Benefits:

  • Opportunities for promotion
  • Professional development

Schedule:

  • Monday to Friday

Supplemental Pay:

  • 13th month salary
  • Yearly bonus

Experience:

  • FDA Regulations: 1 year (Preferred)
  • EDQM: 1 year (Preferred)
  • ICH Q7: 1 year (Preferred)

Language:

  • English (Preferred)
  • Mandarin (Preferred)