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)
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