Quality Assurance Specialist – Inspection & Audit

Evaluate prospective Third-Party Manufacturers, suppliers, and warehouses on the quality of their products, services, and facilities to help the Supply Chain on the selection process.

Job Description
1. Evaluate prospective Third-Party Manufacturers, suppliers, and warehouses on the quality of their products, services, and facilities to help the Supply Chain on the selection process.
2. Performs accurate and timely audits of Third-Party Manufacturers, suppliers and PC accredited warehouses including PC warehouses based on the approved audit calendars.
3. Ensures compliance of manufacturers, suppliers, and all warehouses to cGMP.
4. Discusses audit findings, corrective, and preventive actions with involved parties, ensures implementation of actions and evaluates their effectiveness.
5. Checks TPMs’ procedures and ensures that these are aligned with the standards and procedures set and agreed upon.
6. Provides timely and accurate feedback on audit results.
7. Makes suitable recommendations based on the results of actual audits performed.
8. Performs line inspection to ensure quality products and conformance with set standards and procedures.
9. Performs on-site quality inspection of complained or returned materials and products in different branches and TPMs.
10. Validates non-conformances raised by TPMs.
11. Performs regular evaluation of the whole value chain map based on regulatory compliance and PC requirements.
12. Recommends process enhancements to the immediate superior.
 
Administrative and Operational Efficiency
13. Organizes documentation of all evaluation and audit reports.
14. Provides accurate reports within the specified timetable to the immediate superior.
15. Performs other tasks that may be assigned from time to time.
 
Customer Service
16. Provides immediate feedback to stakeholders on prospective TPMs, suppliers, and warehouses.
17. Provides immediate response on pending issues and concerns.
18. Supports the immediate superior in resolving non-conformances and other concerns by collating pertinent data that will serve as basis for the final disposition.
Qualifications
  • Graduate of BS Chemical Engineering, Chemistry, Pharmacy, Industrial Engineering, or other related courses
  • At least 3 year of work experience in quality control inspection in a manufacturing company or an Audit and Inspection company
  • Knowledgeable in Process and GMP auditing, Raw Material analysis, Packing Material testing and inspection methods applicable to complete the work.
  • Computer literate, good communication skills, knows how to operate basic laboratory instruments.
  • Background in ISO 9001 and other management standards is a plus.
Corporate and Leadership

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