- Compile quality metric data required for management reporting and prepare sections of quality metric reports.
- SOP writing and issuance for site qualification and validation project as and when needed.
- Identify deviations and potential risks in manufacturing systems, processes and methods, and their possible causes.
- Implement validation processes to review systems, methods and processes utilised in manufacturing facilities.
- Access impact to validation for changes that occur during the project and define appropriate validation requirements and approach to meet these requirements.
- Identify potential compliance risk and gaps and recommend improvements.
- Review and approve the validation deliverables related to Facility/Utilities/equipment, computerized system (automation) as well as laboratory equipment/system, further to ensure compliance with company procedures, regulatory requirements and cGMP expectations and meeting project schedule.
- Handling site change control and deviation with other counterpart to meet the project timeline.
- Ensure compliance of site Safety, Health & Environmental (SHE) requirements.
EXPERIENCE REQUIREMENTS
- More than 5 years in a Bio-Lifescience environment, candidate with MNC, Large Organizations or GMP experience will have an advantage.
- Working understanding of Lab/GMP Operations, QC, QA, Process Development, Supply Chain and related functions.
- Involvement in setting up New Site and/or Project Management will be an added advantage.
- Foundational understanding of ICH Q7,Q8, Q9, FDA 21 CFR, Eudralex, PIC/S cGMP guideline.
- Applicant with knowledge in supply management and vendor management will have an advantage.
For interested candidates, please send your most recent and updated resume to [email protected]
Subject heading: Quality Assurance Specialist
Andrea Eunice Tan Min Er
(R23112594)
Recruit Express Pte Ltd
EA License No. 99C4599
