Responsible for the management and maintenance of quality and compliance activities in Zuellig Pharma by ensuring the effective implementation of the Integrated Quality Management System to attain certificates to ISO 9001 and the Zuellig Regional Quality Standards and/or other international standards and to comply with Principals’ requirements.
Duties and Responsibilities
Regional Compliance
Act as Trainor for quality-related trainings and other quality standards such as 5S, cGMP, GSDP, GDPMDD and ZP RQA Guidelines, ISO 9001:2008, etc.
Oversee documentation control / maintenance to ensure compliance with the “good documentation practices” or other documentation requirements of ISO 9001 and other international standards.
Ensure that all issues and concerns regarding quality and compliance are immediately acted upon and/or reported to the Quality and Compliance Group or to the proper concerned authorities.
Conduct regular review of critical quality records such as results of temperature monitoring in the Cold Room and Cool Room, Packaging and Shipment Qualifications/Validations, calibration, pest control, sanitation, preventive maintenance, validation, etc.
Ensure that quality systems and documentation governed by the Good Storage Distribution Practices (GSDP), Good Distribution Practices for Medical Device and Diagnostics (GDPMDD), cGMP and other international standards are implemented and maintained.
Audits
Assist in preparing audit program, plan and conduct internal audits / inspections in the specified branches to check on operational departments’ compliance to established procedures, ISO 9001, GSDP, GDPMDD, cGMP, regulatory and other international standards’ requirements as well as preparation for Principals, Regulatory or other external audits.
In coordination with the various site Managers, may lead the Principal audits and other external audits in the sites as the need arises.
Coordinate and follow through with the Process Owners for the submission of corrective actions on non-conformity reports or deviations. Report to Management on the performance of the Quality Management System as well as the non-conformities observed.
Assist in complying with audits/routine inspection from Regulatory Bodies (FDA/PDEA) and other government agencies.
Administrative Functions
Assist the Quality and Compliance Manager in the conduct of all activities related to the maintenance of the integrated quality management system by ensuring proper controls are in place and in accordance with established standards of cGMP, GSDP, GDPMDD, ISO 9001, GCP or other international standards.
Appointed as Distribution’s Document Administrator.
Assist in spearheading quality initiatives/programs for continual improvement. Support the effective implementation of the various ZP quality innovations / programs.
Supports the Central point person for change control documentation in the branches and assists in the follow-through on closure on changes implemented.
Initiate or suggest improvements or changes in processes or systems to ensure continual improvement.
Submit monthly reports to Management and other required reports as needed in the performance of his/her duties.
Others
Perform other job functions as may be required from time to time or as may be necessary in support of company objectives.
Key Result Areas and Performance Indicators
Support and assistance in the establishment and maintenance of the Quality Management System
ZPC Distribution is Certified to ISO 9001:2015
The various sites of ZPC such as Head Office Distri Operations, Canlubang DC, Sun Valley DC, CTM Sun Valley, and the branches of Cebu and Davao, are all Certified to Good Storage & Distribution Practices
Compliance to ZPC Principals’ requirements
Pass various quality audits by various Principals of ZPC
Timeliness of CAPA submission to various Principals
Internal audit program for ZPC Distribution as well as Suppliers and Platform audits
Timeliness of closure of corrective actions from the IQA
Coordination with various Heads/ Key Personnel of Distribution sites re: RQA-GSDP/ ISO 9001 requirements and various documents required for the IQMS
Timeliness of completion of required documentation
Smooth flow on submission of required documents
Authority Area
Approve/sign-off documents or records as required in the established procedures of Zuellig Pharma.
Review/approve proposals for document revisions through Document Request / Change Notice Form.
Initiate/propose revisions to Quality Procedures/Quality Manual.
Initiate/propose changes or improvements to the quality management system.
Minimum Job Requirements
Education
College graduate of minimum 4-year-course related to sciences or engineering.
Location
Amenable to work in Paranaque Head Office
Related Work Experience
With at least 2 years experience as Internal Quality Auditor of the quality management system.
With at least 2 years experience in Quality Assurance function.
With at least 2 years experience on training
Knowledgeable on quality management systems documentation
Knowledgeable on warehouse/distribution operations.
Competencies
Technical competencies:
GSDP
ISO 9001
GDPMDD
Quality and Compliance
Internal Quality Auditing
Planning
Leadership
Oral and written communication
Business presentation
Business knowledge
Supplier management
Calibration
Knowledgeable in using MS Office applications.
Behavioral Competencies:
Customer service orientation
Ethics and integrity
Diligence and attention to details
Creative thinking
Leadership
Results orientation
Responsiveness
Continuous improvement.
