QA Manager

Job Description Summary

The Quality Manager of the TUAS, Singapore facility reports to the Senior Director, Manufacturing and Design Quality Greater Asia. The primary focus on the Quality Manager is the Quality Management System, Validation, Label Control and Quality Control activities for the manufacture of BACTEC Media products and the shipment of products from the facility. The Quality Manager actively participates in, and aids in the development of the facility Compliance Quality System to ensure that products and operations are in compliance with relevant countries regulations, Business Unit and Corporate requirements. This position assures that products manufactured at the TUAS facility are safe, efficacious and perform as intended, and determines whether products conform to specifications.

**Job Description**:
Who We Are

Job Purpose:
The Quality Manager of the TUAS, Singapore facility reports to the Senior Director, Manufacturing and Design Quality Greater Asia.

The primary focus on the Quality Manager is the Quality Management System, Validation, Label Control and Quality Control activities for the manufacture of BACTEC Media products and the shipment of products from the facility.

The Quality Manager actively participates in, and aids in the development of the facility Compliance Quality System to ensure that products and operations are in compliance with relevant countries regulations, Business Unit and Corporate requirements.

This position assures that products manufactured at the TUAS facility are safe, efficacious and perform as intended, and determines whether products conform to specifications.

Duties & Responsibilities

1. Job Description

1.01 Maintains a team of technically competent staff, independent from Manufacturing and Marketing control, ensures requirements and standards are consistently met.

1.02 Assists the Regional Director of Quality Management in the development as well as implementation, and maintenance of the facility’s Quality System, including policies, procedures and control systems.

1.0 3 Through consultation with R&D and Quality of the Business Unit, develops new test procedures or revises existing test procedures for improvement. Investigates and recommends new method/ equipment for more efficient and/or accurate testing.

1.04 Responsible in the development and maintenance of standard operating and manufacturing procedures that satisfy Business Unit, Corporate and regulatory requirements.

1.05 Dispositions products according to specifications. Assures that backorder situations are kept to minimum through effective management of testing and disposition.

1.06 Responsible for disposition of Quality Notifications for discrepant material and for Quality Notification Board concurrence on a timely basis.

1.07 Responsible for the Documentation System of the plant. (Document Distribution, Batch Records Issuance, Document Retention, Obsolete Documents), etc.

1.08 Serves as the liaison with regulatory agencies when inspected by them. Provides management with report on inspections including a development of assignments for the correction of cited deficiencies and follow-up activities.

1.09 Receives and handles External audits, Business Unit and Corporate internal audits. Responds to audit observations, requests corrective actions and performs follow-up activities.

1.10 Receives and handles inspections performed by customers at BD facility. Issues reports on inspections, requests corrective action report and performs follow-up activities.

1.11 Ensure effectiveness of the QMS such as conducts periodic internal audits using Good Manufacturing Practices, Quality Regulatory Systems, Business Unit and Corporate requirements as audit criteria. Reports results to management and issues follow-up reports for corrective actions.

1.12 Coordinates at BD the Business Unit’s compliance programs. Resolves and discusses regulatory concerns through the Business Unit’s Regulatory Affairs and/or Compliance functions.

1.13 Issues requirements for new products transfer or existing products with significant changes.

1.14 Maintains customer complaint system in coordination with the Business Unit’s Complaint Coordinators to assure prompt investigation and response.

1.15 Maintains stability study program of products to establish and verify established expiration dates and storage conditions.

1.16 Reports on a regular basis the quality level of products produced at the plant.

1.17 Assists in analyzing chronic manufacturing quality problems and makes recommendations for corrective actions/preventive actions.

1.18 Responsible for the implementation and maintenance of the Validation Program of the plant.

1.19 Responsible for the implementation and maintenance of the Equipment Calibration and Preventive Maintenances of the plant.

1.20 Assures laboratory compliance with facility housekeeping regulations and safety procedures.

1.21 Monitors SAP metrics and Business Unit Scorecard