Quality Management Specialist

Job Purpose:

The Quality Specialist will provide assistance to the QMS Manager and the Warehouse Pharmacist on the establishment and implementation of quality management system in Distriphil across all sites. To assist in ensuring quality assurance and regulatory compliance so as to ensure the overall running of the distribution warehouse complies with all regulatory & statutory requirements and that the operation and all outsourced functions are conducted in accordance with Good Warehousing Practice (GWP) and Good Distribution Practices (GDP).

Qualification:

• College Graduate – Science Courses, Industrial Engineer, Pharmacy Assistant, Chemist, etc.
• Good communication
• Planning and organizing Skills
• Computer Skills – Microsoft Word, Excel, PPT, etc.
• Problem-solving skills
• Works well with people
• Customer centric

Key Responsibilities:

Quality Assurance:

Responsible for quarantine and approval of receipt of stocks

Overall QC/QA in warehouse operation

Responsible for Good Housekeeping Practices and Pest Control Management

Responsible for recording of deviations, complaints, non-conforming products, including investigations and actions

Responsible for implementing strict compliance of standard operating procedures

Responsible for rounds and audit of the warehouse

Responsible for documentation control

Responsible for the validations of storages and pack-outs

Responsible for the control of quarantine

Shall assist in internal audits

Responsible in Secondary Repackaging Activity

Responsible for PDEA-controlled drugs storage and distribution.

Regulatory:

Must work with the Regulatory Manager for FDA updates and compliance

Responsible for conducting risk assessment and change control assessment

Must assist and cooperate in product recall activities

Supply Chain:

Support the Supply Chain Head/ Warehouse manager by directing warehouse activities and oversee all aspects of the daily deliveries and order fulfillment.

Monitors activities of work team to ensure that safe practices are in place and being demonstrated.

Other functions:

Must work with QMS Manager for validation and improvement of systems / SOPs