Quality & Regulatory Executive (Contract/MNC)
- 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
- 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: firstname.lastname@example.org
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.
Production / Manufacturing
Public Sector / Government & Statutory Boards
Production / Manufacturing
Contract / Temp
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
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.