JOB DESCRIPTION:

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

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Singapore > Singapore : DUO Tower

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Yes

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)