- Perak Ipoh Perak Malaysia 30350


工作地点
职位描述
任职资格
#Our client is a Pharmaceutical Manufacturing Co.#
Degree in Pharmacy, Biomedical Science, Business, or related fields.
Registered Pharmacist qualification is preferred but not mandatory.
Min 5 years of QA management experience within Pharmaceutical (non-medical devices) industry.
Demonstrate strong knowledge of GMP and regulatory requirements.
Have proven leadership experience managing quality or production teams.
Possess excellent analytical, problem-solving, and communication skills.
岗位职责
#Our client is a Pharmaceutical Manufacturing Co.#
QMS & Compliance
Manage the Quality Management System to ensure GMP compliance.
Improve quality systems through continuous monitoring and enhancements.
Represent the QA department in internal and external quality matters.
Ensure compliance with cGMP, ISO, and GDPMD requirements.
Audits & Inspections
Plan and conduct internal quality audits regularly.
Lead GMP inspections conducted by regulators and customers.
Product Quality
Approve or reject finished products before market release.
Manage product recalls and customer complaints effectively.
Oversee raw material qualification and packaging material approval.
Manage change control, process validation, and Product Quality Reviews.
Documentation
Review and approve Batch Manufacturing Records accurately.
Review and approve Standard Operating Procedures consistently.
Review and approve deviations and corrective actions promptly.
Review and approve Change Control documents properly.
Ensure all quality records remain complete and compliant.
Operations & Team Management
Manage departmental resources to achieve operational objectives.
Support production while maintaining required quality standards.
Lead, coach, and develop the Quality Assurance team.
Manage recruitment, training, and employee performance effectively.
Ensure the team complies with all GMP requirements.
好处
所需技能
重要安全守则
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