Assistant Quality Assurance Manager

Role Responsibilities

• Lead/Perform product evaluation and product failure analysis and investigation.
• Review and evaluates non-conforming product and accept by concessions of incoming and finished products in the absence of QA Operations Manager.
• To assist in managing QA incoming and finished good laboratories.
• Participate in interviews, induction, training and performance evaluation of all QA staffs i.e senior executive and below.
• Identified potential areas for improvement in QMS, EMS and other regulatory requirements.
• Ensures that target agreed for the KPI’s under the responsibility of the position are achieved.
• Devise procedures to inspect and report quality issues.
• To involve in validation activities, stabilities studies.
• Ensure that all relevant quality related reports (both internal and external) are completed and submitted within the stipulated time frame.
• Appraise customers’ requirements and make sure they are satisfied.
• Participate in product design and development process, risk analysis, process validation etc. representing QA operations functions.
• Assist to guide and resolve any issues in QA Incoming, Finished Good and laboratories.
• Handling interlaboratory testing samples & testing.
• To lead and motivate QA operations team to achieve quality objectives and goals and ensure all quality and product performance are well sustain all the time.
• Ensures that target agreed for the KPI’s under the responsibility of the position are achieved.
• Ensuring good manufacturing practice on operations such as incoming material and finished goods inspection and/or release, certification of analysis review and approval for release, product measuring and monitoring control, equipment calibration, etc.
• To assist in ensure the effectiveness of corrective and preventive action taken.
• To assist in ensure the timeliness in replying audit findings.
• Resolve any issues/conflicts in QA Department.
• To ensure all other duties and projects as assigned by the QA Operations Manager.

Role Requirements

• Minimum Bachelor Degree in Science Discipline.
• Knowledge on ISO 13485 Quality Management System and other relevant QMS, products standards and/or national or other medical device regulations.
• Able to speak and write in English & Bahasa Melayu.
• 3 - 5 years’ experience in Quality Assurance.
• Must demonstrated strong analytical skills.
• Independent, good interpersonal & communication skills, team player.
• Familiar with GMP, GLP, ICH guidelines and variants pharmacopeia.
• Able to work in Pontian, Johor.