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 Type: Full-time 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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