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QA Associate - Northwood Mount Vernon

Req #: 17000883_en
Location: Northwood, ENG UK
Job Category: Quality
Date Posted: 12/6/2017 8:51:28 AM
Baxter International
 
Job title:
QA Associate, UK Compounding
Reporting to:
Quality Supervisor / Quality Manager
Issue date:
July 2017
Supersedes:
July 2016
Business:
Medication Delivery
Sub business:
Compounding
Country:
UK
Location:
Compounding Units
Job Code:
ZQ1300
BPG:
D
 

SUMMARY

 
Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality.
 
Responsible for release of product from the system. 
Responsible for supporting production in the review and post compounding check operations.
 
Responsible for documenting and investigating out of limits results and Complaints using Quality Incident, NCR, CAPA and Complaint processes.
 
Responsible for supporting implementation of the Baxter quality system within the compound unit ensuring regulatory compliance.
 
 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

 
  1. Final check and Release of Finished products
    • Responsible for release activities associated with products manufactured at the compounding units.
 
  1. Review of Customer Orders
    • Responsible for the Review of prescriptions on Merlin.
 

ADDITIONAL QUALITY SYSTEMS SUPPORT

 
  1. GMP and Facilities and Equipment Control
    • Investigation of out of limits results using Quality Incident, NCR and CAPA processes.
 
  1. Quality System Measurement and Review
    • Support outcomes, decisions and actions of the review.
    • Ensure meeting actions are completed to agreed deadlines.
    • Support the tracking and trending of quality system data, including but not limited to Quality Incidents, NCR’s, CAPA and Complaints.
 
  1. Complaints
    • Completing Complaint Investigations
    • Responsible for reporting any complaints that may result in Field Corrective Action immediately to the Business management representative and also the European FCA gatekeeper
    • Reporting any adverse events to Pharmacovigilance and the Business management representative
 
  1. Quality Incidents
    • Ensure that any Quality Incident is documented.
    • Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated
    • Leading and coordinating investigations.
 
  1. Corrective and Preventative Action
    • CAPA owner and leader
    • Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames
    • Raising supplier corrective actions to address out of specification raw material issues
 
 
 
 

Education 

 
Science degree e.g. Pharmacy, Chemistry, Microbiology or equivalent
BTech- Pharmaceutical Science or equivalent work experience
 
English GCSE or equivalent
 

Experience

 
Breadth & Depth of experience
2 years experience of working in a aseptic compounding operation
12 months experience of quality system implementation
Field of expertise:
Ideally experience in all or any of the following:
Batch review / release
Root cause investigation and problem solving techniques
Quality system management and implementation
 

Skills

 
 
Language skills
 
Languages
Spoken
Written
Read
 
 
 
 
English
Excellent
Excellent especially report writing
Excellent
Computer Skills
Familiar and comfortable with using MS Office, including Excel and Word. Advanced practitioner in Excel
 
  Basic
MS Word, email systems, PowerPoint Visio
  Particular knowledge required
TCu, ISOtrain, SharePoint and Trackwise
 
Advanced knowledge of Excel
 
 
 
 
Technical skills
 
  • Report writing
  • Problem solving
  • Continuous improvement techniques
  • Risk management tools and methods
 
 
 

 
 

 

 
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