EXECUTIVE, QUALITY

GENERAL DESCRIPTION

The Quality Officer in the healthcare industry will be responsible for Quality, Environment, OH&S, GDP, GDPMD, 5S, ABMS, Risk Management System processes are established, implemented and maintained, and to support the overall business objectives of Pharmaserv Alliances Sdn Bhd.

JOB DESCRIPTION

1.      Quality Management IMS.GDPMD

• Ensure quality, Environment, OH&S Management System process and GDPMD regulatory compliances system are established, implemented and maintained.

• Report to “top management” on the IMS and where improvements are needed, also the performance of the GDPMD regulatory compliance system, as well as to identify and correct deviations from the established GDPMD regulatory compliance system.

• Ensure all company policies, procedures, and works instructions are documented in a clear, simple and concise manner.

• Conduct GDPMD, safety, quality and environmental system compliance audits.

• Control and maintain the company audit and risk assessment schedule and report.

• Ensure internal auditors appointed have received appropriate training and are assessed as competent to perform tasks.

• Ensure that everyone in the organization is aware of policy and requirements by conducting training for new and existing procedures. Train all staff / personnel in documented company policies.

• Liaising with the external parties on matters relating to the Malaysian Medical Device Regulatory requirements, GDPMD and Quality, Environment, OH&S Management System matters.

• Ensuring awareness on obligations to comply with the regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout establishment and supply chain.

• To conduct audits as per defined guidelines – ISO 9001, ISO14001, ISO45001, GDP, GDPMD, ISO13485, 5S/QE, ISO37001 & others.

• To maintain and draft quality assurance policy and procedures if needed.

• To evaluate audit findings.

• To comply documents for internal audits and other quality assurance activities.

• To monitor and recommend, thus, develop corrective and preventive actions.

• To ensure alignment with Group standards.

• Perform Quarterly Quality report submission.

• Performance Monitoring and Reporting – HOS to report on their quality objectives and carried out all actions and controls defined.

• Implement continuous improvement and best practices.

• Coordination for accreditation or certifications.

• Participation in Group Quality Meeting.

• Compile and report on Quality Objective performance, and progress towards targets.

2.      Risk & Compliance Officer

a)     Compliance

• 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 verify and review all 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.

• To submit Healthshoppe Compliance reporting.

• Attend compulsory and related training.

b)     Risk Management

• Coordinate risk identifications, analysis, monitoring and reporting at Service/Department level.

• Consolidate and document pertinent Service/Department level risks into the Company risk register.

• Prepares various reports, slideshows, documents and forms (Pharmaserv and Healtshoppe).

c)      Business Continuity Management

• Implement and execute Group Business Continuity management (BCM) policies.

• Involve in preparing, coordinating and reporting Business Continuity (BCP) Test as required in Group BCM Framework

• Develop Business Impact Assessment (BIA), update (where required) and compile BIA from all Services/Department.

• Develop and update (where required) relevant Business Continuity Plan (BCP) documents.

• Conduct BCP drills and submit report to GRCI (Pharmaserv and Healthshoppe).

• Collaborate with internal teams to ensure seamless execution of business continuity management implement as a plan.

d)     Incident Reporting

• Non-compliance incidents to be reported immediately via email to GRCI.

• Immediately notify GRCI on Sentinel event or Major Non-Clinical Incident within 24 hours.

• Monthly incident declaration to GRCI, by 7th of every month.

• 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.

3.      Outsourced Vendors

• Visit, meeting, audit and collaborate with outsourced vendors, and with relevant stakeholders to streamline processes, and enhance operational efficiency.

• Leverage outsourced vendor feedback and data analytics to refine staff happiness.

• Build and maintain strong relationships with outsourced vendor and partners to drive employee satisfaction.

• Negotiate contracts, pricing, and terms to secure cost saving and partnerships.

• Review, verify and compile outsourced vendor monthly report.

4.      Occupational, Safety and Health Coordinator

• Involved in regulatory and control work of workplaces under the jurisdiction of the legislation.

• Inspecting and investigating of workplace to ensure compliance with the regulations are carry out, as well as to assist in the training and development of staff.

• Responds to and investigates concerns and complaints from workers/employers and takes appropriate action.

• Investigates accidents and injuries that occur in the workplace.

• Responsible for the establishment of, and monitors the performance of, workplace safety and health committee.

• Participate in the delivery of related educational programs and disseminates information to the Company.

• Liaising on matters relating Safety and health at workplace and proceed for OSH Certification.

• Develop Occupational Health and Safety System, including polices, procedures and manuals and to communicate with management on safety programmes.

• To implement and maintain HIRARC exercise.

5.      Sustainability Champion / CSR

• Perform Monthly Sustainability report submission.

• Providing regular reports and updates to management on the progress and outcomes of implemented activities.

• Develop ESG activities in support of embedding and strengthening social culture and awareness at the Company.

6.      Other Responsibilities

• Monitor 5S/QE/award.

• Monitor agreement and Compliance.

• Ensure adherence to KPJ’s CARE.

• Perform other related duties as assigned.

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JOB REQUIREMENT

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

Professional Qualification: Safety and health Officer Certificate

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

Skills & Competencies:

Special skills required

• Maintain positive relations between employees and the organization.
• Developing programs and initiatives boost employee satisfaction and engagement.
• Promote employee growth, set clear expectations, and hold employees accountable.
• Minimum of one year experience in the occupational safety and health field.

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.
• Flexible, and ability to maintain good relationships with all levels of staff.
• Ability to maintain effective work relationships. Good organizational skills.
• Excellent communication skills. Good oral and written communication skills.