Senior Pharmacist
Job Function
Quality Assurance
Job Summary
The Senior Executive - Quality Assurance ensures that quality control activities adhere to production schedule and inspects incoming, in-process and outgoing products/shipments for adherence to quality requirements. He/She implements customized Quality Plans for individual customers and recommends solutions to address quality queries, customer complaints and audit requirements. He should be well-versed in regulatory affairs and compliance standards to align the organisation's QMS with international and national regulatory standards for compliance.
In addition, he/she implements initiatives to encourage continuous improvement and enhance department operations. He/She also designs documentation guidelines and templates, as well as delivers quality-related training.
The Senior Executive - Quality Assurance has an analytical mindset and is able to manage priorities and address multi-faceted issues effectively. He/She has strong communication skills which enables him/her to interact effectively with groups of internal and external stakeholders.
Job Responsibilities/Key Tasks(External)
Manage customer relationships
• Maintain records and documentation of customer engagements.
• Address customer requests that deviate from signed contractual agreement at the guidance of the manager.
• Address customer dissatisfaction of products, service standards while working with relevant parties to resolve issues.
• Recommend and review product services/ technical nuances related to product and services and/or product and service offerings.
Manage people, finance and organisational development
• Coordinate with cross-departmental teams and external stakeholders to deliver work outcomes.
• Facilitate department's retention efforts.
• Engage in on-the-job training and performance improvement opportunities.
Contribute to continuous improvement and technology advancement
• Facilitate research on product and material development to enhance product value for customers.
• Facilitate the adoption of technologies, electronic tools and system upgrades to support productivity and innovation.
• Identify trends and patterns in data from quality audit reports using basic data analytics tools.
• Implement lean practices for Quality activities.
• Monitor gaps in Quality processes and procedures and identify opportunities for improvement.
Manage quality framework and operations
• Monitor quality plan framework, strategy and operating structures to support business objectives and priorities.
• Support various teams such as Supply Chain Operations, Regulatory Affairs, Procurement and Business Development in their alignment to the established QA framework
• Implement approved quality procedures, standards and specifications.
• Implement customized Quality Plan for individual customers.
• Implement Supplier Quality Management for services and products.
• Generate validation studies reports.
Facilitate achievement of quality expectations and standards
• Monitor Quality activities and generate monthly report for near miss, complaints, non-conformance products and deviation reports and ensure the results to meet KPIs.
• Conduct internal and external quality audit programmes.
• Recommend process improvements to address identified product quality issues.
• Perform complaint management activities, including investigation and vigilance reporting, quality incidence (non-conformity), and deviation and incidents handling and reporting.
Manage Quality related training
• Deliver training on QMS, regulatory and other requirements.
• Develop training programmes and materials for QMS, regulatory and other requirements.
• Analyse training outcomes to identify gaps and design new and revised training programmes accordingly.
Job Requirements
Professional Qualifications & Relevant Experience
• Recognised Diploma / Degree n Pharmaceutical Science or relevant with at least 3 years experience
• Registered Pharmacist licence is preferred.