*URGENT* QA Specialist (Pharma MNC/ West/ Up to $4000) HCG
We are hiring Contract QASpecialist to be outsourced to our client from reputable organisations!
- Responsible to review and approve master batch records and subsequent batch records
- 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.
- 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 and external audits
- 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:
Attention to: Celestine Goh
Or call Celestine @ 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