Job Description

• Industry/ Organization Type: Scientific Research/ Development
• Position Title: Quality Assurance Specialist
• Working Location: Buona Vista (Walk distance from MRT)
• Working Hours: 5 days (8.30 am to 5.30 pm)
• Salary Package: Basic (Up to $6k) + Variable Bonus + Medical Insurance
• Duration: Permanent Role

Key Responsibilities

• 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 approaches to meet these requirements.
• Identify potential compliance risks 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 counterparts to meet the project timeline.
• Ensure compliance with site Safety, Health & Environmental (SHE) requirements.

APPLY NOW!!!

• More than 5 years in a Bio-Lifescience environment; candidates 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 Sites and/or Project Management will be an added advantage.
• Foundational understanding of ICH Q7,Q8, Q9, FDA 21 CFR, Eudralex, PIC/S cGMP guideline.
• Applicants with knowledge of supply management and vendor management will have an advantage.
• Self-starter, self-motivated - effective in being an individual contributor and team player with other Functions.
• Excellent communication skills both verbal and written.

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