Oversee and execute a comprehensive range of duties and responsibilities encompassing strategic planning, operational oversight, and team leadership. Collaborate with cross-functional departments to align objectives, ensure seamless workflows, and drive project execution. Monitor performance metrics, identify areas for improvement, and implement corrective actions to optimize efficiency and productivity. Foster a culture of accountability, innovation, and continuous development through mentorship, coaching, and professional growth initiatives. Maintain compliance with organizational policies, industry regulations, and best practices while upholding high standards of quality and service delivery. Prepare and present detailed reports, analyze data trends, and provide actionable insights to senior leadership to inform decision-making.
Purpose:
Oversee and enhance the interconnected Quality Management System (QMS) spanning warehouse and supply chain functions to uphold adherence to ISO 9001 standards and pharmaceutical regulatory requirements.
Oversee cross-functional quality assurance initiatives to ensure adherence to GDP, GSP, and PCN compliance, pharmacovigilance obligations, cold chain management protocols, inventory traceability standards, and controlled medicines handling procedures.
Coordinate enterprise-wide document control systems, encompassing the management of Standard Operating Procedures (SOPs), quality manuals, Corrective and Preventive Action (CAPA) documentation, deviation records, audit-related materials, and training compliance frameworks.
Oversee intricate quality investigations encompassing deviations, non-conformities, temperature excursions, customer complaints, inventory discrepancies, and operational failures, with a focus on conducting thorough root cause analyses and implementing robust Corrective and Preventive Actions (CAPA).
Oversee the administration of pharmacovigilance activities, ensuring the timely escalation of adverse drug reactions, thorough investigation of product quality complaints, and adherence to regulatory reporting obligations in accordance with established standards.
Perform comprehensive quality risk evaluations and establish preventive measures to mitigate operational, financial, compliance, and reputational risks.
Assist in regulatory licensing initiatives, conduct PCN inspections, facilitate ISO certification procedures, perform partner audits, and manage external compliance evaluations.
Examine quality trends, compliance data, audit results, and operational performance metrics to pinpoint systemic inefficiencies and establish enduring process enhancements.
Spearhead ongoing enhancement efforts aimed at bolstering operational efficiency, advancing compliance maturity, elevating service quality, and optimizing overall organizational performance.
Facilitates meaningful interactions and fosters strong connections with stakeholders to enhance collaboration and alignment with organizational goals. Consistently seeks opportunities to engage audiences through tailored communication strategies, ensuring active participation and sustained interest. Monitors engagement metrics to evaluate effectiveness and refine approaches for maximum impact. Prioritizes building trust and rapport to strengthen relationships and drive long-term commitment.
Collaborate with warehouse, procurement, logistics, pharmacy, and management teams to ensure alignment with organizational quality objectives, compliance priorities, and operational standards.
Act as the central liaison for managing internal audits, mock audits, external audits, certification processes, and regulatory inspections, maintaining a state of perpetual audit preparedness.
Partner with diverse teams across the organization to enhance integrated operational controls, strengthen compliance frameworks, and optimize service delivery processes.
Drive enterprise-wide quality and compliance training programs focusing on ISO 9001, Good Distribution Practices (GDP), Good Storage Practices (GSP), pharmacovigilance, Corrective and Preventive Action (CAPA) systems, Product Change Notification (PCN) requirements, and Standard Operating Procedure (SOP) adherence.
Liaise effectively with regulatory agencies, auditors, certification entities, suppliers, and partners regarding quality, compliance, and regulatory affairs.
Support informed strategic decisions by producing high-quality reports, developing KPI dashboards, conducting risk analyses, tracking compliance trends, and delivering operational quality insights.
We provide timely and reliable delivery services to ensure your orders reach their destination efficiently and securely. All deliveries are handled by trained professionals who adhere to strict safety and quality standards. Customers can expect transparent tracking and real-time updates throughout the shipping process. Our team commits to fulfilling delivery requests promptly, maintaining open communication to address any concerns or special requests.
Deliver exceptional service quality consistently by skillfully managing quality systems, operational controls, and regulatory compliance initiatives.
Ensure all Corrective and Preventive Actions (Caps), deviations, audit findings, pharmacovigilance tasks, and compliance action plans are closed promptly in accordance with established deadlines.
Ensure meticulous maintenance of documentation integrity, data precision, process traceability, and adherence to operational compliance throughout warehouse and supply chain operations.
Monitor key performance indicators related to quality and assist in management review processes by providing practical recommendations aimed at enhancing operational efficiency and quality standards.
Foster a culture characterized by accountability, ongoing enhancement, and adherence to quality and regulatory standards throughout all operational teams.
Facilitate the achievement, renewal, and ongoing compliance of ISO 9001 and related quality and regulatory standards to ensure sustained certification and adherence to requirements.
Enhance quality management systems and streamline integrated operational processes to facilitate organizational expansion, scalability, operational robustness, and elevated customer satisfaction.
Seeking an individual with a deep understanding of specialized subjects pertinent to the role, demonstrating both technical expertise and practical application in the relevant field. Candidates must exhibit a comprehensive grasp of key concepts, methodologies, and industry-specific challenges to effectively contribute to strategic initiatives and problem-solving efforts. Proficiency in applying specialized knowledge to real-world scenarios is essential, ensuring alignment with organizational objectives and advancements in the domain.
A Bachelor of Pharmacy (B. Pharm) degree is mandatory for this position.
A valid practicing license issued by the PCN is required.
Seeking candidates with one to two years of hands-on experience in pharmaceutical quality assurance, warehouse operations, pharmacovigilance, regulatory compliance, or supply chain quality management.
Proven track record in overseeing ISO 9001 integration, Quality Management System (QMS) coordination, audit administration, regulatory inspections, Corrective and Preventive Action (CAPA) management, and continuous quality compliance monitoring.
Proficiency in GDP, GSP, ISO 9001 standards, pharmacovigilance requirements, PCN regulations, quality risk management systems, cold chain management, and pharmaceutical quality standards is essential.
Proven expertise in managing quality enhancement projects, regulatory documentation frameworks, and compliance protocols within strictly regulated healthcare or pharmaceutical settings.
Relevant quality management certifications, including ISO 9001 Internal Auditor credentials, would be beneficial to possess.
Skilled in utilizing Microsoft Office Suite, ERP systems, inventory management systems, quality documentation systems, and data analysis/reporting tools.
Analytical acumen, leadership capabilities, adept stakeholder management, strong organizational aptitude, project coordination expertise, and adept problem-solving skills are essential, complemented by a meticulous attention to detail.
Competitive benefits are offered, including comprehensive health, dental, and vision insurance coverage, along with a generous retirement savings plan featuring company matching contributions. Paid time off encompasses vacation, sick leave, and holidays, while additional perks may include professional development opportunities, flexible work arrangements, wellness programs, and employee discounts. Other potential advantages could consist of life and disability insurance, tuition reimbursement, and wellness allowances.
Comprehensive health coverage is provided as part of the total compensation package. This benefit includes medical, dental, and vision insurance options, ensuring employees and their eligible dependents have access to quality healthcare services. Participation in the plan may require employees to meet eligibility criteria and contribute a portion of the premium based on their chosen coverage levels. Additional wellness programs and resources are also available to support overall health and well-being.
Delivers a competitive performance bonus based on individual and team achievements, aligning with company goals and ensuring equitable distribution across eligible roles.
We are pleased to offer a 13th month pay as part of the comprehensive compensation package. This benefit is provided annually and amounts to one month’s salary, disbursed alongside regular monthly earnings. Eligibility for this payment is determined by continuous service throughout the calendar year, in accordance with applicable labor regulations and company policy.
Conduct an annual evaluation of professional skills to gauge current competencies and identify areas for development.
Qualifications
BA/BSc/HND
Experience Required
1 - 2 years
