QA Manager – Port Klang (Ref ID: 11555)
・To manage QA department and to ensure effective QA operations through proper implementation of quality management system inclusive of Change Control Management, Product Quality Review and Quality Risk Management.
・To ensure continuous improvement of QA activities through regular reviewing of SOPs, manufacturing procedures & distribution control, evaluating & undertaking corrective actions to eradicate defects/problems.
・To support department budgeting and planning and to ensure the execution of relevant tasks in order to materialize the budgeted items.
・To act as an authorized person for product release and ensure that the products are released in timely fashion in accordance with GMP and other regulations, aligned with production planning and delivery schedule
・Maintain a well-trained & highly-skilled talents in QA team through effective training & development, formal and informal face-to-face meetings/conversations, motivation and performance appraisal process.
・Support new & existing product registration (local & overseas) through compilation and submission of BMR, certificate of analysis to Regulatory Affairs Department.
・Ensure that products are produced, stored & distributed following the relevant guidelines and requirements.
・Facilitation, monitoring and tracking of all internal and external audits to ensure full completion and compliance of the corrective and preventive actions in a timely manner.
・Ensure customer satisfaction with regards to product quality through recording and evaluation of product complaints, post-market surveillance study with their investigation & implementation of corrective and preventive actions to improve product quality.
・Conduct thorough investigation and analysis, undertake shopfloor inspections/visits and Gemba walk where necessary to enable continuous improvement of processes and operations to minimize complaints.
・Implement and monitor Quality-related KPIs across the QA department.
・Record, track, and maintain relevant data and present progress to upper management in a timely manner through weekly/monthly and ad-hoc reports.
・Embraces a “team” working environment focused on achieving department goals by demonstrating willingness to accept assignments not specifically listed above as allowed by the limitations of training, experience, and/or education.
・Above Diploma holder in Chemistry, Microbiology or equivalent
・Working experience with min 8 – 10 years in Pharmaceutical Industry or Manufacturing Field
・QA requirements of pharmaceutical manufacturing plant to meet GMP requirements