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
- 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.
- Monday to Friday
- 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
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Job IdJD923999
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationGelang Patah, Malaysia
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EducationNot mentioned