JOB SUMMARY:
Reporting Line: Senior QA Manager
Working Location: Me Linh Point, 02 Ngo Duc Ke, District 1, Ho Chi Minh
MAIN PURPOSE OF ROLE
Ensure quality system and its activities comply with Abbott Global Quality requirements, Local regulations
Ensure quality elements are monitored, and quality process are followed by partners.
Ensure product quality at affiliate level
MAIN RESPONSIBILITIES
- Full-responsible for Labeling Control
Instruct and Supervise Labeling Procedure to ensure labelling, packaging activities are consistent with Abbott and local Regulatory labelling requirement
Manage labeling profile (Masterfile, Labeling matrix). Ensure this huge and frequent updated profile not being mixed up/ wrong labeling.
Be SME in Labeling control. Coordinate labeling activities between marketing, 3A QA and warehouse, ensure labeling effectiveness (no waste, no supply chain interruption due to labeling activities)
- Manage QA related supplier with full responsibility
Coordinate with Procurement screen all suppliers to list down which under scope for QA control
Evaluate, Control & Performance monitor all QA related suppliers according to new One Abbott supplier management process.
Train appropriate stakeholders on One Abbott supplier management process
- Support Affiliate CFH/CRM with quality, technical information, interview and train CFH candidates.
- Coordinate with CFH, Management board and MF or Investigator to solve the Serious quality complain
- Defect (Internal complain) monitoring:
Thoroughly handle internal complaints from Logistics, Warehouses, 3A QA at affiliate level (guideline preparation, training, categorization, defect certification, staff sale utilization)
Report quality issue, communicate and coordinate for investigations.
Manage Defect KPI for Quality Management. Ensure every trend identified at early stage and appropriate action be applied to minimize crisis or for improvement
Coordinate with 3A to support on quality aspects (technical information, standard procedures). Directly communicate with 3A QA relating quality issue, recognize any potent that can lead to quality issue and propose corrective and preventive actions and lead corrective action plan until effectiveness confirm
Recognize/identify any gap of current procedures/SOPs. Self-revise and create new procedures/SOPs with more expanded scopes, innovative way of action
- Take part in projects as coordinators/ SME:
Take part in Global, Regional projects (eg. Cross-affiliate internal auditor) and affiliate projects.
Support other partners on QA respective (Regional, Global and TPM QA projects, especially to audit Deneast on behalf of TPM QA)
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Work Experience
Experience
Minimum 3-5 years
Education
Bachelor
- Science in Biology, Biotechnology, Food chemistry, Pharmacy or equivalent
CORE Skills Required
Professional Skill
Comprehensive QA in Healthcare industry knowledge
Pay attention to detail & execution.
Strong interpersonal skills
Problem solving skill
Behavioral / Leadership Skill
Compliance, honest, trustful
Adaptive, innovative, and teamwork.
Self-driven team player
Continuous improvement behavior
Possess good organization, planning, problem analysis
Language Skill
- English fluency in listening, speaking and document writing
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