Quality Assurance Specialist (Operation) - 1 year Contract - Abbott Pharmaceutical

Abbott

  • Ho Chi Minh City
  • Permanent
  • Full-time
  • 1 month ago
JOB DESCRIPTION:ABOUT ABBOTTAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.WORKING AT ABBOTTAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
  • Career development with an international company where you can grow the career you dream of.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
ROLES & RESPONSIBILITIES1, 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 REQUIREDWork 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
The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: EPD Established PharmaLOCATION: Vietnam
Ho Chi Minh City : Me Linh Point TowerADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Not specifiedMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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