Job Information
Abbott Quality Assurance Manager in Singapore, Singapore
Core Job Responsibilities
Quality Assurance
Quality System
Implement and manage local quality systems and training programs as necessary to support CAPA, complaint handling, inspection reporting and tracking, policy implementation, supplier management, document and change control management, distribution and material control
Develop and maintain Quality Management System Manual while minimizing cost increases and potential disruptions to business. Ensure the implementation and maintenance of activities related to compliance to policies, processes, procedures and plans that define these elements necessary to meet the Quality objectives, along with Regulatory and business requirements
Represent the affiliate in projects or issues as required
Interpret, evaluate and update management on local regulatory regulations, requirements and standards.
Provide integrated QA support in QA related issues for EPD Supply Chain
Provide support to local outsourcing activities and product launches through management of the First Lot Quality Review program
Assure that all distributed products in Singapore conform to current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Company Corporate and Divisional Quality standards, and other applicable regulatory standards.
Responsible for management of local over-labeling / redressing activities and ensure the activities comply with GMP, Company Corporate and Divisional Quality standards and local regulatory standards.
Provide instructor-led training for quality activities and systems such as DARIUS, ISOtrain and SolTRAQs.
Responsibilities for document creation and maintenance in DARIUS
Perform ISOtrain training coordinator role to create courses, modules, generate monthly reports and carryout reconciliation of overdue trainings.
Quality Metrics
Ensures implementation of quality metrics at Affiliate level, including adherence to set targets and goals.
Maintain Management Review process for Affiliate and elevate any significant events or identified risks to management.
Quality Complaints
Register all non-medical/medical QA related complaints via SolTRAQs and forward complaint to the manufacturing site for investigation
Close complaint record and communicate to complainant
Handles non-medical complaints - receipt, investigation, evaluation, response, closure and maintenance
Work with Global Security and HSA for any Counterfeit, Diversions, Tampering, Theft issue
Quality Audit Program /Supplier Management
Manage Internal Audit/self-inspection at Commercial Affiliate to ensure effectiveness of Quality System Implementation
Act as the key Affiliate contact for both internal audits and Regulatory Authority inspections
Responsible for supplier management of local suppliers including qualification and performance monitoring
Ensure compliance of imported and TPM product labeling as per regulatory approval
Managing potential on-market issues for local and imported product including TPM products, to document decisions and all Agency communications/actions
Position Accountability / Scope
QA:
The role is responsible for ensuring that the affiliate implement and maintain cost effective quality systems solutions and remain in compliance with regulatory requirements. Failure to meet this goal can result in the BU not fulfilling the commitments of the region/division or corporate compliance plans. Financial penalties to the division, regulatory action and/or wasted resources are possible consequences. As importantly, the quality of products is a competitive advantage in the market place, and any lessening of our standards can have an adverse long-term impact on our business.
Minimum Education
Bachelor of Science degree or equivalent
Minimum Experience/ Knowledge Required
Minimum 4-5 years of quality assurance experience in pharmaceutical industry. PV experience is preferred
Ability to take the lead in driving projects and initiatives
Executive presence to participate in Leadership meetings and discussions
Fluent in English ability to communicate both in written and orally, to all levels of management and across different cultural backgrounds
Well-developed interpersonal, negotiation and stakeholder management skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com