Contract QA Lab Specialist with Validation Experience (Pharma MNC) - HNL
WE ARE HIRING CONTRACT QA LAB SPECIALIST WITH VALIDATION EXPERIENCE FOR VARIOUS PHARMACEUTICAL / MEDICAL MNC TO BE OUTSOURCED TO OUR CLIENT.
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
- Ability to interact effectively in teams and facilitate team discussions
Experienced and interested candidates are invited to email your resume to: [Click Here to Email Your Resume].
Or, call Nicholas at 67363280 / 88751135 for further enquiries.
Please include your contact number, full working experience, education background, notice period, expected salary.
Nicholas Low Wen Jie
Recruit Express Pte Ltd Company Reg. No. 199601303W
EA License Number: 99C4599
*We regret only suitable candidates will be shortlisted for an interview.
Recruit Express Pte Ltd