QA Specialist (API Pharmaceutical/Up $4,000)

Location Singapore
Discipline Engineering
Job Reference BBBH128343_1686002402
Salary S$4000 - S$5000 per month
Consultant Name Winnie Chen Hsiu Wen
Consultant Name Winnie Chen Hsiu Wen
Consultant Email [email protected]
Consultant Contact No.
Consultant Contact No. 6232 5258
EA License No. 02C3423
Consultant Registration No. R1980765
Consultant Registration No. R1980765

Job Responsibilities:

  • Review and approve GMP documentation and ensure their compliance to Quality Standards (QS).
  • Ensure adherence to quality procedures, regulatory requirements and cGMPs.
  • Improve quality assurance systems, as necessary.
  • Maintain current quality tracking systems and the quality metrics to proactively identify trends and atypical observations.
  • 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
  • Qualify and manage suppliers according to Quality Standards (QS) and maintain accurate records of supplier status.
  • Review and analyze the quality related issues from suppliers and recommend improvement action to mitigate compliance risk.
  • Ensure supplier and material is qualified timeline to support production schedule.

Job Qualifications:

  • Degree holder in Science / Chemical Engineering or equivalent.
  • Possess good organizational skills, adaptable to change, open to new ideas.
  • Great team ethic, with an ability to operate both on own initiative and as part of a team.
  • Good communication skills, including verbal, written and graphical representation.
  • Proficiency in Microsoft Office, especially MS Excel, Word, PowerPoint.

Winnie Chen Hsiu-Wen EA License No.: 02C3423 Personnel Registration No.: R1980765

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