Lead in the implementation of Quality Management System in accordance with internal company policies and procedures, cGMP and other international regulations.
Update complaints retrieved from various sources to complaint log in a timely manner and escalate complaints into the CAPA system following review.
Participate in Product Quality activities by reviewing test protocols and reports to ensure product quality meet the specified requirements.
Review deviation and risk management for products as required.
Review product quality documents and provide documents related to product quality upon request.
Provide management with quality data and trends
Lead internal audits to ensure the effective implementation of Quality Management System.
Lead audits in CMOs to ensure compliance to all relevant guidelines, regulations and agreements.
Support other projects and activities as assigned.
Education/Qualification
Degree in Engineering (Biomedical) or Degree in Science (Biology, Chemistry, Bio-engineering)
Experience in quality function dealing with Biopharmaceuticals with more than 1 year experience.
Skills preferred
Effective oral and written communication skill
Strong analytical and problem-solving skill
Good computer skills, inclined to adapt to technology efficiently
Good knowledge of regulatory guidelines
Results-oriented, multi-tasking, quick learner
Works independently and well under tight deadlines
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