*URGENT* QA Specialist (Pharma MNC/ West/ Up to $4000) HCG

Recruit Express Pte Ltd | Date Posted: 8-Nov-2018
EA Licence No: 99C4599 | EA Personal Registration No: R1658827
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Job Nature:
Contract
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

We are hiring Contract QASpecialist 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 guidelines.
  • 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.
  • Min. 3 relavant years of experience in QA 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.
  • Able to commit to a 1 Year Contract role

 

Qualified applicants, please send in your resume to: 

[Click Here to Email Your Resume]

Attention to: Celestine Goh

Or call Celestine @ 6736 3280 for a short discussion

Please include your full working experience, education background, notice period, expected salary.

Recruit Express Pte Ltd Company Reg. No. 199601303W | EA License Number: 99C4599

We regret to inform that only suitable candidates will be shortlisted for an interview.

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Recruit Express Pte Ltd