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Quality & Regulatory Executive (Contract/MNC)

Description

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.


Industry

Production / Manufacturing
Public Sector / Government & Statutory Boards


Specialization

Production / Manufacturing


Location

West


Employment Type

Contract / Temp


Salary

S$2,601 - S$4,000 / mth
S$4,001 - S$6,000 / mth


If you meet the requirements of this role, please email a detailed resume in Word document to Melanie Zheng Zhiyuan.
CEI Registration No.: R1104774
Email: recruitmedical@recruitexpress.com.sg
Tel: 67363280
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.