Senior Specialist, QA
Baxter
- Hà Nội
- Lâu dài
- Toàn thời gian
- Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
- Responsible for complaint related processes and ensure procedure compliance.
- Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
- Immediate follow-up of potential Medical or Adverse Event product complaints according to corporate requirements.
- Report, follow-up and trend product complaints.
- Responsible for FA related actions viz. customer notification letters, regulatory reporting and product recall activities.
- Reply to customer complaint, queries related to quality, presentation to customer on quality.
- Responsible for release of Finished Goods with temperature controlled and after routine redressing.
- Disposition of Damage products
- Responsible for redressing instruction.
- Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
- Oversee documentation to ensure completion of records and GDP Compliance
- Prepares SOP, Document Change Request (DCRs) and Periodic Review.
- Ensure compliance with SOPs, quality assurance, internal and local regulations.
- Responsible for managing suppliers with the support of supplier quality function.
- Assist with data gathering and analysis for Quality Reviews/Complaint to ensure occurs at required frequency.
- Responsible for complaint related processes and ensure procedure compliance.
- Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
- Immediate follow-up of potential Medical or Adverse Event product complaints according to corporate requirements.
- Report, follow-up and trend product complaints.
- Responsible for FA related actions viz. customer notification letters, regulatory reporting and product recall activities.
- Reply to customer complaint, queries related to quality, presentation to customer on quality.
- Responsible for release of Finished Goods with temperature controlled and after routine redressing.
- Disposition of Damage products
- Responsible for redressing instruction.
- Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
- Oversee documentation to ensure completion of records and GDP Compliance
- Prepares SOP, Document Change Request (DCRs) and Periodic Review.
- Ensure compliance with SOPs, quality assurance, internal and local regulations.
- Responsible for managing suppliers with the support of supplier quality function.
- Assist with data gathering and analysis for Quality Reviews/Complaint to ensure occurs at required frequency.
- Discipline to adhere with quality and compliance requirement.
- Must have good verbal and written communication skills
- Excellent teamwork and coordination skills
- Good sense of urgency and strong follow up
- Able to work independently with little or no supervision
- Discipline to adhere with quality and compliance requirement.
- Organized and high level of accountability on documentation
- Resourceful, self-reliant, self-motivated and confident.
- Language – English competency is a must
- · Bachelor’s degree and above, majoring in pharmacy is an advantage.
- Minimum 5 years of work experience with quality role in a Healthcare setting, preferably in a MNC organization.