Contract Quality Assurance Executive (Pharma Manufacturing / West ) - HMZT
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!
- 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
- 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.
Recruit Express Pte Ltd