Purpose:
The Senior QA Specialist is responsible for independently providing Commercial Quality support in the affiliate. Scope of activities includes quality system requirements associated with: pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas of support may include Storage and Distribution, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. The Senior QA Specialist has an in- depth knowledge of one or more elements and is considered a subject matter expert in these areas. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.
Responsibilities:
Scope of work encompasses the markets of Singapore and the Philippines, with ad hoc support for Malaysia, Indonesia, and Brunei as required.
- Responsible for the integration of local quality regulations for drugs, biologics, device and/or combination products and cosmetics.
- Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
- Maintain and coordinate all Quality Management Activities for GDPMD/S for Singapore, and provide ad-hoc support for Good Distribution Practice for Medical Device Malaysia (GDPMD).
- Develop, manage, and implement quality principles to ensure effective compliance of the affiliate quality system with AbbVie policies, processes and procedures and all applicable regulations and industry standards, including establishment and maintenance of local procedures, work instructions, records, and all applicable quality system documents.
- Coordinate and investigate quality events such as deviations, nonconformities, complaints, and corresponding action plans to assure continuous improvement of product and quality systems.
- Overlook affiliate redressing activities (e.g. overlabeling, redressing) to ensure compliance with requirements and minimize risk.
- Managing internal and external quality inspections and audits (including reporting, response to observations and tracking of action plans).
- Support supplier qualification program for the affiliate including audits, quality agreements and performance monitoring.
- Quality management of medical devices (e.g. vaporizers)
- Coordinate change control process to ensure changes do not introduce negative impacts to operation.
- Provide guidance and support for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature shipments.
- Coordinate and support all activities related to product actions (recalls, withdrawals, corrections, etc.) in the affiliate, in collaboration with affiliate Regulatory Affairs and General Manager.
- Coordinate the Management Review process for the affiliate.
- Coordinate quality training program: develop and implement quality system training to ensure compliance with identified quality goals and standards and that promotes the highest level of quality and compliance.
- Responsible for establishing and carrying out a quality self-inspection program within the affiliate.
- Communicate with internal and external customers on all quality and compliance-related matters.
- Evaluate, analyze, and trend quality indicators, data, and performance metrics; communication and elevation of affiliate compliance status and risk while maintaining a continuous improvement objective.
- Ensure metrics and KPIs are being met.
- Develop and execute quality plans as needed and provide guidance and assistance to the various multi-disciplinary departments and teams with respect to planning and execution.
- Represent affiliate QA in regional, global, and cross-functional teams, projects, and programs, as assigned by management.