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Closing Date: 12th November 2018
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Recruit Express Pte Ltd
 
Singapore’s Largest & Most Preferred Recruitment Company!
As a premier leading recruitment consultancy in Singapore, our success has been a result of our focus in facilitating the success of our Clients in business whilst enhancing the career opportunities for our Candidates.

With our swift expansion across the region, we now have offices in Singapore, Taiwan, Sydney, Kuala Lumpur and Hongkong as well as a partner network in Shanghai and Japan.

We serve with distinction and provide comprehensive staffing needs. As the total recruitment and staffing solutions partner, our goal is to provide our Clients the best staffing solutions through an integrated database network supported by localized content and services.

EA Licence No.: 99C4599
Contract Quality Assurance Executive (Pharma/Manufacturing) - HMZT

Salary: 4900

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.
  • Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
  • 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 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: recruitmedical@recruitexpress.com.sg

Attention to: Cindy Ng Yu Ling

Or call Cindy @ 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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