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Quality Assurance Specialist

Posted about 2 months ago

Location Brussels Job Type Permanent
Salary Competitive + bonus + package Sector Quality Management, Quality Assurance

Quality Assurance Specialist

 

Brussels

 

Competitive salary + package

 

Permanent / CDI

 

 

We are working with a multinational client with decades of market experience in supplying pharmaceutical and biotech companies with small to commercial scale cGMP (Good Manufacturing Practice) peptide API (Active Pharmaceutical Ingredient) manufacturing, using world-class production processes.

 

The Quality Assurance Specialist will ensure that the products are manufactured, stored and packaged in accordance with cGMP. 


He / she will also support the development of GMP training packages and, if necessary, delivery of training. Under the direction of the reporting manager, he / she will continuously improve QA and Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections.

 

The QA Specialist is reporting to the Head of Quality

 

Principle Responsibilities of the Job Holder

 

Provide QA support for

 

  • Investigation and closure for the Deviation and the Out Of Specifications
  • Change Control initiation and implementation
  • CAPA initiation and implementation
  • Documentation and records review
  • Procedure, Master Batch Record, Specifications
  • Batch records and associated documents after production
  • Control Cleaning Records
  • Maintain the calibration program and the monitoring for the facilities up to date

 

  • Documentation System Management
    • Traceability (controlled copy, follow-up approvals,…)
    • Official documents distribution
    • Maintain the training files and the archives area up to date

 

  • Other activities
    • Work with relevant departments to ensure timely closure of quality actions
    • Actively contribute to continuous improvement initiatives
    • Perform inspections/internal audits
    • Collaborate with the different departments to resolve compliance matters

 

Key Competencies Necessary to Effectively Perform this Job Role

 

  • Minimum qualifications Master degree Sciences
  • Professionnal experience required Min.5 years in a QA position

 

Specific skills required

  • Good knowledge of cGMP in a regulated environment (ICH Guidelines)
  • Excellent accuracy and attention to detail
  • Excellent interpersonal skills
  • Working knowledge of MS office packages (Word, Excel, Power Point) and TrackWise® System is in asset
  • Strong problems solving skills, issue resolution and root cause analysis
  • Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment
  • Language: English / French

 

Please send an English language CV, along with any supporting cover notes with your application.