- Responsible for the quality and meeting the applicable Company requirements and local regulations for the products that the local operation company (LOC) markets in Taiwan.
- Responsible for compliance with the Company Quality Policy, Standards and SOPs that are applicable to the activities the LOC undertakes. Ensure that a quality management system is implemented and maintained according to Quality Manual.
Plans, coordinates, and directs quality assurance programs designed to ensurecontinuous supply of products consistent with established standards byperforming the following duties personally or through subordinates.
Duties & Responsibilities:
- Perform the daily activities of the business quality in the LOC and assist with implementation of Quality Management System to local operating company
- Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws.
- Trains, plans, schedules and assigns work, appraises performance and resolves problems/issues.
- Conducts and tracks quality investigations and process deviations and follows up to ensure corrective action has been taken appropriately
- Investigates non-conformances relevant to the product quality marketed by the LOC and the quality related processes performed in the LOC.
- Provides oversight/monitor complaints handling, quality issue reporting, field actions, change management, risk management, document management, and qualification & training program are implemented and in accordance with company and/or health authority guidelines
- Assist in the documentation of corrective actions plans (CAPAs) and monitor implementation
- Conduct gap assessments on global standard operating procedures to local procedures
- Create local implementation documents for procedures that’s deviated from global SOPs
- Approves changes to documentation and processes.
- Support in communication and activities with external distributor and/or suppliers
- Responsible for monitoring of purchasing control and supplier management program; monitor and update the Approved Supplier List (ASL)
- Responsible to monitor and update the local operating company quality manual
- Make product disposition decision for products with quality issues and local relabelled products. Monitors quality metrics for trending purposes. Reviews, for approval or rejection, all procedures or specifications impacting on the quality of the company products marketed by the LOC.
- Assist in preparation and oversight of escalation management to and from regional/global office
- Assist with preparation of Quality System Management Review
- Ensure audit readiness according to company quality policy standards and applicable procedures.
- Support internal and external audit; conduct audit to distributors, 3rd party service providers, GxP related suppliers
- Minimum of 2 – 4 years of experience in quality in pharmaceutical or related industry
- Experience in conducting training
- Knowledge of local Health Authority regulations
- Demonstrated attention to details
- Excellent written and spoken communication and presentation skills
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
- Sound judgment, strong planning and organizational skills, and the ability to get things done
- Demonstrated strong sense of urgency
Johnson & Johnson Taiwan, Ltd. (8580)