about the company
As a result of ongoing and continued successes both within Singapore and internationally, a global leader is recruiting a potential Quality Assurance Specialist to join them in their expansion.
about the job
The Quality Assurance Specialist implements validation processes to identify deviations and potential risks in the manufacturing processes. You are responsible for first-line verification of quality standards in the organisation and support the product release and registration process by collaborating with other departments to gather relevant information. In addition, you assist in audits, handle quality queries, deliver quality-related training, and is responsible for ensuring that documents are organised and managed according to standard procedures and requirements. The Quality Assurance Specialist communicates with customers on product enquiries and develops practical solutions to implement workflow improvements and enhance department operations.
- 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.
skills & experience required
To be successful in this position, you must have the ability to demonstrate or possess:
- Degree in Biotechnology
- 5 years+ experience in a Bio-life science environment/GMP experience
- 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.
how to apply
If you believe you have the right skillset, experience and drive to succeed, please apply now. Alternatively, please dropped an email to lauren.ang(@)randstad.com.sg for any further discussion.
EA: 94C3609 / R1333505
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