Contract Pharma Lab QA Senior Specialist ( Lab Equipment Validation)
Recruit Express Pte Ltd| Date Posted: 15-Jun-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
Bachelor's / Honours
ROLES & RESPOSIBILTIES:
- Review and approve GMP documentation and ensure compliance to Company’s standards
- Ensure adherence to quality procedures, regulatory requirements and cGMPs.
- Improve quality assurance systems, as necessary.
- Review and approve laboratory equipment /system qualification documentation according to the site procedures. This includes reviewing and approving the laboratory equipment qualification documentation and operating procedures, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact. Ensure issues are escalated according to the Company’s Quality Standards.
- Maintain inspection readiness and support inspections from regulatory agencies and customers.
- Support the maintenance of validated stated of GMP systems and processes.
- Min. Bachelor Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience
- At least 1-3 years of experience in a pharmaceutical or related industry
- Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, GAMP 5, Good Documentation Practices (GDP), and other applicable regulations
- Strong knowledge in laboratory equipment/system qualification lifecycle and ALOA principles and data integrity requirement related to laboratory equipment
- Successful track record of continuous improvement, development, and/or implementation of best practices in quality operations or manufacturing
- Previous Quality Assurance and GMP Compliance experience
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd