Quality And Compliance Manager (pharma/biotech Mfg, Gelang Patah)

Gelang Patah, Malaysia

Job Description

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  • Implement EHS policies and procedures
  • Prepare HAZOP and aspect/impact register
  • Coordinate with R&D/Production for tech transfer
  • Identify and resolve rate-limiting steps in manufacturing processes
  • Propose strategies for optimal facility utilization
  • Lead COGs reduction projects
  • Monitor compliance with cGMP and regulatory standards
  • Review production operation instructions
  • Ensure the availability of relevant documents for batch initiation
  • Coordinate document preparation
  • Report and investigate deviations and ensure closure within initial timelines
  • Implement CAPA and ensure timely closure of audits
  • Manage employee training
  • Coordinate impact assessments and customer complaints
  • Ensure equipment qualification and shift marking
  • Prepare and approve the department\'s organizational chart
  • Periodically review Quality and GMP of the area
  • Prepare operational and quality matrix reports
  • Participate in management reviews
  • Coordinate budgets
  • Manage team members
Job Requirements
  • A Bachelor\'s or Master\'s degree in Chemical Engineering or Pharmaceutical Sciences.
  • A minimum of 5 years of experience in a pharmaceutical manufacturing role, with demonstrated expertise in EHS, tech transfer, process improvement, and regulatory compliance.
  • Strong knowledge of cGMP and global regulatory standards.
  • Must be able to work in Gelang Patah.
*A detailed JD will be given upon request. Job Types: Full-time, Permanent Salary: RM6,000.00 - RM10,000.00 per month Schedule:
  • Monday to Friday
Application Question(s):
  • Do you have working experience as Quality and Compliance Manager? If yes, how many years?
  • Do you have experience expertise in EHS, tech transfer, process improvement, and regulatory compliance?
  • Do you have knowledge of cGMP and global regulatory standards?
  • Able to work in Gelang Patah?

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Job Detail

  • Job Id
    JD936666
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Gelang Patah, Malaysia
  • Education
    Not mentioned