EXECUTIVE, QUALITY ASSURANCE Full Time

The Quality Assurance (QA) in the healthcare industry will be responsible for ensuring that products and services meet the established set by company focusing on Warehouse process at Pharmaserv Alliances Sdn. Bhd.

Job Description

• Quality Management (ISO9001/ ISO14001/ ISO45001/ GDPMD/ GDP):
• Ensure quality, Environment, OH&S Management System process and GDPMD / GDP regulatory compliances system are established, implemented and maintained.
• Reporting issues to HOS on Quality Management and where improvements are needed, also the performance of the GDPMD/ GDP regulatory compliance system, as well as to identify and correct deviations from the established GDPMD/ GDP regulatory compliance system.
• Ensure all company policies, procedures, and works instructions are documented in a clear, simple and concise manner
• Oversee employees GDPMD, GDP, safety, quality and environmental system compliance audits.
• Develop, execute test plans and cases, Perform visual inspections and quality tests
• Issues Management : Identify, document, track and report defects, or non-conformances
• Prepare the company audit and report.
• Prepare the temperature mapping report
• Ensure that everyone in the organization is aware of policy and requirements.
• Liaising with the external parties on matters relating to the Malaysian Medical Device Regulatory requirements, GDPMD and Quality, Environment, OH&S Management System matters.
• To conduct yearly audits as per defined guidelines – ISO 9001, ISO14001, ISO45001, GDP, GDPMD, ISO13485 & others.
• To maintain and draft quality assurance policy and procedures if needed.
• To evaluate audit findings, compile documents for internal audits and other quality assurance activities.
• Identifying defects, designing and executing test
• To monitor and recommend, thus, collaborating with teams to implement corrective and preventive actions.
• Analyzing data and overseeing strategy.
• Perform Quarterly Quality report submission.
• Performance Monitoring and Reporting – to report to HOS, carried out all actions and controls defined.
• Process Improvement: Create and update procedures, monitor risk and Implement continuous improvement and best practices.
• Participation in departmental Quality, Risk and Safety Meeting.
• Compliance:
• Ensure adherence to company standards, industry regulations and safety guidelines
• Identify relevant legislative requirements.
• Identify and engage with Regulatory Bodies to understand their needs and requirements.
• To ensure compliance with all relevant Acts, Rules and Regulations.
• To maintain a register on all regulatory submission deadlines and monitor the compliance.
• To review documents and information’s (based on the regulatory requirements) prior to the submission to the regulatory / enforcement bodies.
• Ongoing duties include to keep reporting and informed about changes in laws and regulations.
• Risk Management:
• Prepare risk identifications, analysis, monitoring and reporting at Service/ Department level.
• Develop outreach and engagement activities in support of embedding and strengthening risk management culture and awareness at the Company.
• Incident Reporting:
• Non-compliance incidents to be reported immediately to HOS and Top Management
• Support the investigation of incidents, near-misses, or crisis to identify root cause and corrective actions.
• Document incident reports and follow up on remediation actions to prevent recurrence.
• Coordinate Root Cause Analysis (RCA) session for new incidents.
• Other Responsibilities :
• Visit, meeting, audit and collaborate with transporter/outsource vendors, and with relevant stakeholders to streamline processes, and enhance operational efficiency.
• Leverage transporter/ outsourced vendor feedback and data analytics to refine staff happiness.
• Build and maintain strong relationships with transporter/ outsourced vendor and partners to drive customer satisfaction.
• Review, verify and compile transporter/ outsourced vendor report.

JOB REQUIREMENT

Education: Bachelor’s Degree in Science, or related discipline.

Professional Qualification: Warehouse / Hub Management Certificate

Knowledge and Experiences: Minimum of 3 years of experience in Quality Assurance with at least 2 years in a managerial Quality, Environmental, OSH, GDPMD, GDP & Risk Management within the healthcare industry (medical devices, pharmaceuticals, healthcare services, etc.).

Skills & Competencies

Special skills required

• Strong analytical, observation and problem-solving skills.
• Excellent attention to detail and communication (written/ verbal)
• Knowledge of quality management systems (e.g. ISO, GDP)
• Maintain positive relations between employees, stakeholders and the organization.

Personal attributes

• Knowledge, Abilities and Skills Working knowledge of The Workplace Safety and Health Act and related legislation.
• Ability to work independently and collaborate effectively in a team environment.
• Proactive approach to managing their time and tasks, in meeting the project timeline.
• Work with a positive attitude and enthusiasm, even when faced with tight deadlines or challenging projects.
• Productive, ability to produce accurate and thorough quality of work, resilient/ resourceful under pressure, display confidence, positive thinker, high discipline, cooperative, responsible, reliable, dependable, good leadership, high integrity.
• Knowledge of enforcement procedures.