Quality Manager

RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES
1. Quality Management Systems
Ensure that the Quality System is established, implemented and maintained to meet the requirements of ISO 9001 and other relevant Quality Systems and PPE regulation.
Report the Quality System effectiveness to Top Management and Management Team and make recommendation for improvements.
Ensure the promotion of awareness of QMS, regulatory and customers' requirements throughout the Ansell plant.
Ensure that processes needed for the quality management systems are established, implemented, maintained and effective.
Any other duties as assigned by the Reporting Manager.
2. QMS Management Review
Organize and conduct the scheduled QMS Management Review Meeting.
Review the suitability and effectiveness of the Quality System.
3. QMS Internal Audit
Lead auditor of the local Internal Audit team
Lead the team and ensure effectiveness of QMS Internal audits.
4. External Audit
Be the liaison person and Quality Management Representative for all external audits.
5. Regulatory Affairs
Ensure quality system is in compliance with regulatory and legislative requirements.
Manage and maintain the regulatory and legislative documentation related to the products and Quality System.
6. Control of Non-conforming Products.
Ensure effective control of non-conforming product.
Authorize the disposition of non-conforming products.
7. CAPA
Drive timely and effective CAPA resolution.
8. SOP
Manage the QMS documentation System.
9. Quality Records
Manage the quality records storage and retention system.
10. Providing Technical Support to Manufacturing.
Provide technical and quality advice related to trouble shooting of new/ existing manufacturing/ quality problem.
Provide technical and quality advice related to new raw material evaluation & implementation and procedural changes.
Provide technical and quality advice related to process and product improvement.
11. Incoming, In-process & Final Release Product Inspection and Certification.
Manage and maintain effectiveness of Incoming, In-process & Final Release Inspection activities for Ansell Vina.
Authorize finished product releases and approve on product conformance certificates.
12. Validations
Manage the function of process, raw material and equipment change validation of the company.
Support in new product validation and design & development.
Support software validation carried out in the company to ensure compliance with QMS & GMPs.
13. Customer Complaint
Administer Customer Complaint System for the company.
Lead and ensure effective customer complaints handling and resolution.
14. Laboratory Testing and Calibration
Ensure continued accreditation of QC Lab against ISO/IEC 17025.
Administer the laboratory testing/ inspection activities which include incoming materials, in-process solutions/ compounds/ product, finished product and effluent testing as well as environment control.
Provide necessary support in inter-plant product testing and benchmarking program.
Administer the Calibration Program of the company concerning testing/ inspection and relevant measuring and process control equipment.
15. Supplier / Vendor Evaluation
Assist in the process of supplier / vendor evaluation and ensure compliance with the Quality System.
16. CMR & SHE
Carry out assigned responsibilities related to CMR &SHE.
SHE Steering Committee member.
17. Subordinates
Inventory, recommend and provide training to ensure the QA and Lab personnel have adequate skills to carry out their responsibilities and to consistently improve the quality of work.
Recruit, promote and take disciplinary actions as the situation demands with respect to QA and lab personnel.
Develop subordinates through training, delegation, coaching and other techniques to maintain organization effectiveness.
18. Others
Coordinate the implementation of Global Procedures or standardization.
Provide the necessary support for the new product, process and software validation.
Be the liaison person among the marketing, technical support and manufacturing functions for product improvement and matching to the plant's capability.
Participate in and support continuous improvement initiatives.
Work to standardize processes across factories.
Participate in inter-plant audits as requested.
Meet corporate compliance EMS and SHE requirements.
Support implementation efforts of Six Sigma and World-Class Manufacturing in the plant.
Participate in local Standards Committees where relevant.
Any other duties as assigned by her Superior.
AUTHORITY
Decision pertaining to regulatory and legislative requirements on Quality Systems and Products.
Decision pertaining to the disposition of non-conforming products
Decision pertaining to non-conformances or deviations in Quality System and processes.
Decision pertaining to non-conformities reported during internal and external audit.
Decision pertaining to Validations.
Decision pertaining to raw material & product acceptance criteria/ quality.
Decision pertaining to Product Release and Certification.
Decision pertaining to Administration and activities of QA Department.
Authorization of QA staff's annual leaves.
Carry out performance appraisal for his subordinates.