Contract Quality Assurance Executive (Pharma Manufacturing / West ) - HMZT

Recruit Express Pte Ltd | Date Posted: 17-Jan-2019
EA Licence No: 99C4599 | EA Personal Registration No: R1104774
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Job Nature:
Contract
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

We are hiring a Contract Quality Assurance Executive to be outsourced to our clients in the pharmaceutical manufacturing sector. Qualified applicants are invited to apply!

Job Scope

  • Responsible to review and approve master batch records and subsequent batch records associated with the manufacturing, packaging and labeling of intermediates and API to ensure batches produced are in compliance
  • 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.
  • Improve quality assurance systems, as necessary.
  • 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 audits to ensure the internal controls are effective. Conduct external audits to ensure adequate oversight to suppliers and collaborate with supplier to reduce starting material quality issues.
  • 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 Quality Assurance and GMP Compliance
  • Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
  • 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: Felix Yeoh

Or call Felix @ 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