Assistant Quality Assurance Manager – Quality Excellence

Departments: Quality Assurance
Job Locations: Melaka

Duties and Responsibilities:

  • Manage the entire Quality Excellence team to drive compliance of the quality management system at site.
  • Establish, maintain and control overall management of Site Master Plan, Quality policy, Company Procedure, SOP deployment and other relevant quality system documentation.
  • Lead in Document Center Management, establish a system, to implement, manage and track the archival system to comply to document retention requirement.
  • Co-lead with IT functions in Electronic Quality System E-tools from design, validate, implement to maintain.
  • Manage overall Validation Master Plan inclusive of Computer System Validation, and ensure other relevant validations are performed timely at site.
  • Manage overall Audit Management (mainly internal audit, regulatory, certification body and health authority audit)
  • Lead in Management Review, Post Market Surveillance, Risk Management, Product Quality Review inclusive Stability Study Trending, On-going verification of product performance
  • Lead in GMP & GxP Qualification Training Program, working closely within Quality department and cross functional team, on technical aspect of the training needs of respective individual/group of employees.
  • Establish Recall Management and escalation process
  • Lead in Complaints Management, establish end-to-end governance process upon complaint receipt throughout till closure with customer. Complaint Management inclusive Pharmacovigilance, Call Center supports, Health & Hazard Evaluation
  • Lead in failure investigation (Deviation), perform root cause analysis and identify quality and effective CAPA, to avoid recurrence of similar root cause.
  • Lead in change control process with different triggers, which may lead to different action plan, impact assessment and implementation approach.
  • Deployment and implementation of Good Distribution/Good Warehouse Practice

Minimum Requirements:

  • Minimum 3 years working experience in the quality assurance, quality control or related functions in a manufacturing operation.
  • Experience in the management of Quality Assurance Programs for pharmaceutical and prior statistical background will be an added advantage.
  • Good knowledge of ISO and PIC/S regulations and cGMP is required.
  • Excellent interpersonal and communication skills (speaking and writing in English) and able to work independently.
  • Attention to detail, possess planning and organizing skills, judgment skills and decision-making skills, critical thinking, fast tempo.
  • Proficient in Microsoft Office applications.

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