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

•    Poly Grads with relevant experience on min 3 years
•    Grads with relevant industry discipline