Contract Quality Assurance Specialist (Pharma MNC/ $5000)

Recruit Express Pte Ltd| Date Posted: 11-Jun-2019
EA Licence No: 99C4599|EA Personal Registration No: R1981653
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Job Nature:
Contract
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

We are hiring Contract QA Specialist to be outsourced to our client from reputable organisations!

 

Job Scope

  • Responsible to review and approve master batch records and subsequent batch records
  • Review and approve cleaning records and procedures and ensure compliance with set
  • Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
  • Review and approve deviations according to the site procedures
  • Handle product complaints.
  • Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
  • Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
  • Conduct internal and external audits
  • Maintain inspection readiness and support inspections from regulatory agencies and customers.
  • Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
  • Support the maintenance of validated stated of GMP systems and processes.
  • Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

  • A Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
  • Minimum 1-3 relevant years of experience in QA/QC and GMP Compliance
  • Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
  • Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good
  • Documentation Practices and other applicable regulations.
  • Proven track record of continuous improvement in quality operations or manufacturing.

 

All qualified applicants, please send in your resume to:
[Click Here to Email Your Resume]
Attention to: Tricia Goh, QA Specialist
Or call 6736 3280 for a short discussion


Please include your full working experience, education background, notice period, expected salary.
We regret to inform that only suitable candidates will be shortlisted for an interview.


Tricia Celestine Goh (R1981653)

Recruit Express Pte Ltd

Company Reg. No. 199601303W | EA License Number: 99C4599

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Recruit Express Pte Ltd