ROLES & RESPONSIBILITIES

1, Summary:

Quality System implementation at the local EPD Commercial site and assures that quality related matters associated with products commercially distributed including those from Local TPM conform to current Good Manufacturing Practices (cGMP), Abbott Quality standards, and other applicable regulatory standards.

2, Core job responsibilities:

2.1. Quality Operation:

Join the operation of QMS to manage and maintain the quality activities in the Vietnam affiliate and ensure the safety, quality and benefit of the products that were imported.

Complaint/ Pharmacovigilance coordinator:

• Register, coordinate all non-medical/medical QA related complaints via SolTraq and forward complaint to manufacturing site for investigation, monitor CAPA implementation.
• Monitor and evaluate returned products, complained product samples, counterfeit suspected product, damaged goods.
• Close complaint record and communicate to complainant
• Join the investigation for any Counterfeit, Diversions, Tampering, Theft issue, discrepancy of promotional material.
• Track and trend for complaint at affiliate, provide the escalation and actions when required.

Exception and CAPA Management Responsibilities

• Procedure Oversight and Reporting: Compile and track compliance with procedures: Exception Management, Root Cause Analysis, Corrective and Preventive Action (CAPA), Planned Deviation
• SolTRAQs System Coordinator: Maintain logs and track closure of exceptions and planned deviations, CAPA and effectiveness check. Collaborate with SMEs for investigation, CAPA decisions, and product impact assessments. Assign new due dates and approve extension requests in consultation with QA Manager. Support departments with SolTRAQs queries and liaise with GSD for system issues
• Report periodically on:
  • Quality metrics related to NC, PNC, PDV, and CAPA
  • Status of initiated exceptions and CAPAs
  • ER and CAPA status to regional teams (if required)
  • Track and trend for complaint at affiliate, provide the escalation and actions when required

Supplier Management

• Monitor the supplier management of local suppliers including qualification and performance evaluation, maintain the approved supplier list.
• Ensure the supplier notification change is communicate on time to impacted departments for proper action plan.
• Involve in Quality Technical Agreements
• Provide integrated QA support in QA related issues for EPD Supply Chain

Product launch, distribution

• Review and evaluate temperature data when receiving information from Distributor and submit for to CDQAM for deicsion.
• Provide support to local outsourcing activities and product launches through management of the First Lot Quality Review program.

2.2. FIE project:

Join in preparing SOPs, layouts for the quality management system of warehouse (operation parts) when the warehouse is set up, ensure the document system meet GSP requirements, Abbott policy. Support the validation of new warehouse set up which includes but not limited to mapping, computerized system validation for warehouse management system, building monitoring system and environment monitoring system... Support the audit readiness about:

• Join the internal audits/ gemba at new warehouse to define the gap/ room improvement and define actions on time.
• Backroom management for DAV audit to ensure the audit is executed smoothly, front room SME in DAV audit for relevant areas.

2.3. Identify continuous improvement opportunities on error, action, root cause analysis, corrective action, preventive action, general improvement opportunities at affiliates and related distributors, warehouse.

2.4. Other work/function/ job rotation that may be assigned.

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED

Work Experience:

• Pharmacist at least 3 years’ experience in Pharmaceutical or medical device (or related industry) QA/Regulatory
• Experience with FIE warehouse or QA manufacturing site.

Core Skill Requirement

• Adaptability, Initiative, Integrity
• Planning and Organizing
• Ability to prioritize
• Ability to use Quality Tools and Quality IT systems such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making, ISOTrain, SolTRAQs
• Project management and troubleshooting skills
• Fluent in English
• Knowledge of local regulations for quality systems and compliance
• Ability to identify problems, and initiate corrective actions and preventative actions
• Sound decision-making skills contributing to high levels of competence, confidence and credibility are required
• Well-developed interpersonal, communication and negotiation skills
• Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.)
• Change management
• Strong regulatory and GxP compliance