Implement and manage quality systems and training programs to support , validation, complaints, inspection reporting, supplier management, and document control.
Maintain the Commercial Quality Management System Manual while ensuring compliance, minimizing costs, and avoiding business disruptions.
Ensure adherence to company policies, procedures, regulatory standards, and business requirements to meet quality objectives.
Interpret and evaluate local market regulatory requirements and quality standards.
Provide integrated QA support to Supply Chain activities and operations.
Support outsourcing activities and product launches through the First Lot Quality Review program.
Ensure distributed products meet GMP, GDP, corporate standards, and regulatory requirements for safety, authenticity, and compliance.
Register all QA-related complaints in the system and forward them to the manufacturing site for investigation.
Communicate outcomes and close complaint records with timely feedback to complainants.
Handle non-medical complaints, including receipt, investigation, evaluation, response, and closure.
Conduct internal audits and self-inspections to ensure the effectiveness of Quality System implementation.
Manage supplier qualification, performance monitoring, and compliance of local suppliers.
Ensure labelling compliance of imported and company products according to regulatory approval.
Manage potential on-market issues for both local and imported products, documenting all decisions and regulatory communications.
Act as the Designated Person ensuring regulatory compliance, reporting system performance to management, and liaising with external parties on medical device requirements.
Job Requirements :
Preferably candidate graduate from Bachelor’s Degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Biomedical Science, Quality Management, or a related field.
Preferably with QA / PV experience in a pharmaceutical company
Strong attention to detail
Proficient in computer applications (Windows, MS Office)
Good command of English, both written and spoken
Effective communication skills with internal and external stakeholders
For those who have what it takes, please apply online or send in your profile to :
Consultant : Wong
Tel : 03 -
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Qa Executive • SelangorMalaysia, Selangor, Malaysia