Job Description
The Quality Control Senior Specialist is the frontline compliance expert responsible for validating and ensuring the daily execution of all quality assurance standards and procedures within the Distribution Centers.
This role is critical for operational quality checks, conducting practical testing of new standards, and driving detailed investigation (RCA) of all non-conformities and deviations.
Accountabilities
- The responsibilities are focused on Operational Compliance, Testing, and Deviation Investigation.
- 1. Standards Execution and Validation (Operational QC)
- Standards Intake: Receive, study, and thoroughly understand all set quality standards, testing protocols, and Standard Operating Procedures (SOPs) defined by the central Quality Assurance (QA) team.
- Testing and Simulation: Conduct hands-on testing and practical simulations of new or revised standards within the operational DC environment to verify their feasibility, efficiency, and compliance before full-scale rollout.
- Daily Compliance Checks: Perform routine and spot checks on DC operations, covering areas such as temperature mapping, inventory segregation, security, goods receipt, dispatch quality, and equipment calibration records, ensuring adherence to established QC standards.
- Implementation Assurance: Be accountable for ensuring the correct, consistent, and effective implementation of all approved QA standards by operational staff across the Distribution Center.
- 2. Deviation and Investigation Management
- Deviation Detection & Reporting: Continuously monitor and immediately report all deviations, non-conformances, or operational breaches from the defined QC standards and regulatory requirements (e.g., Good Distribution Practice - GDP).
- Root Cause Analysis (RCA): Lead the formal investigation process for all critical deviations and non-conformances. Conduct thorough Root Cause Analysis (RCA) to accurately identify the underlying systemic, procedural, or human factors contributing to the deviation.
- Documentation and Handover: Document the deviation and the complete RCA findings (including evidence, investigation steps, and root cause summary) in a formal report. This report is then submitted to the QA team, enabling them to recommend appropriate Corrective and Preventative Actions (CAPA).
- 3. Training and Continuous Improvement
- Knowledge Transfer: Assist the QA team in translating complex standards into practical, on-the-floor training for DC operations staff and QC inspectors.
- Feedback Mechanism: Provide crucial practical feedback to the central QA team regarding the execution challenges, unexpected outcomes, or process improvements observed during the testing and implementation phase.
- Audit Support: Support internal and external audits by providing evidence of daily QC checks, deviation investigation records, and compliance implementation status within the Distribution Center.
Employee’s duties are not limited only to the above-mentioned Accountabilities; he/she may perform other duties as assigned.
Work Environment
- Indoors : 90%
- Outdoors : 10%
- Working Days : 5 Working Days
- Days off : 2 Days Off
- Working Hours : 8:30 AM – 5:30 PM
Job Requirement
Education
Bachelor's Degree in Pharmacy, Industrial Engineering, Quality Management, or a related scientific/technical field.
Experience
Minimum of 4-6 years of direct experience in a Quality Control (QC) or hands-on compliance role within a large-scale Distribution Center, preferably in the pharmaceutical or healthcare industry.
Computer Skills
- MS Office Suite
- Awareness of the ERP System
Languages
