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 stocks
- Over – all 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 Validations of storages and pack-outs
- Responsible for control of quarantine
- Shall assist in internal audits
- Responsible in Secondary Repackaging Activity
- Responsible in 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
