Quality Assurance Specialist

Malia Group

Job Purpose

Responsible for the proper and timely implementation of Quality Assurance Policies & Procedures.


Responsible for advising on needed changes and improvements by providing training, tools & techniques allowing others to achieve set quality standards.


Responsible for conducting internal inspections and quality audits in a timely manner.


Perform duties in accordance with Malia Group Policies and Procedures.


Duties And Responsibilities

On GMP Documentation management and Qualification


- Write, update, and submit Standard Operating Procedures (SOPs) and work instructions for all departments to Senior QA for review


- Perform packaging validation, room/equipment qualification, and mapping to ensure alignment with GMP guidelines


- Conduct supplier evaluations and assessments as part of the supplier management system


- Oversee Environmental Monitoring & Calibration, ensuring accuracy and adherence to shelf-life standards, and maintain calibration certificates


- Organize and deliver training sessions for plant staff on updated SOPs, GMP requirements, and other relevant topics as per the training schedule




On Inspection and Auditing


- Conduct regular plant inspections and internal audits to ensure GMP compliance, document findings, and address non-conformities


- Oversee sampling, manufacturing, and packaging operations by reviewing checklists, logbooks, and ensuring data accuracy


- Review batch files for compliance, investigate discrepancies, and document corrective actions in deviation and incident reports


- Issue quality forms (DIR, OOS, RA, CAPA, CCF) and ensure follow-up actions are taken to mitigate risks


- Evaluate machine components and implement corrective/preventive actions to maintain product quality


- Coordinate with external companies for pest control tours, ensuring a pest-free environment


- Conduct Gemba Walks, prepare HIRA forms, and submit them to the EHS manager to ensure alignment with safety standards


- Handle sustainability topics (Ecovadis, EHS checklists) and ensure alignment with company goals




On Reporting


- Assist departments in preparing forms (e.g., DIR, OOS, CAPA) to ensure consistent reporting and documentation


- Compile data for production reviews, waste percentages, and analytical insights


- Report monthly non-conformance observations, follow up with department heads, and ensure corrective actions are implemented


- Prepare and submit trend analysis and product annual reviews to the QA Lead for review


Education And Experience

Education

Bachelor Degree in Chemistry and any related field


Experience

Fresh graduate or up to 1 year of experience in related field